FDA Orange Book · active-ingredient family
Cetirizine hydrochloride
Cetirizine hydrochloride: 8 brands, 64 generics; first approved Sep 27, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 64 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
8
Generics (ANDA)
64
Listed patents
11
Next patent expiry
Feb 11, 2030
in 3 yr 7 mo
Brand (NDA) products
Originator applications
- KENVUE BRANDSNDA 02162120205 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL OTC — 5MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL Discontinued — 2.5MG TABLET, CHEWABLE ORAL OTC — - ESTEVENDA 2114152019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - HARROW EYENDA 2086942017
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.24% BASE SOLUTION/DROPS OPHTHALMIC Rx — - KENVUE BRANDSNDA 0225782010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - BIONPHARMANDA 02242920094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG CAPSULE ORAL OTC — 10MG CAPSULE ORAL OTC — 5MG CAPSULE ORAL OTC — 10MG CAPSULE ORAL OTC — - KENVUE BRANDSNDA 02215520072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - KENVUE BRANDSNDA 01983520074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - ZYRTECRLDJ AND J CONSUMER INCNDA 0203461996
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued —
Generic (ANDA) products (64)
Abbreviated applications
- CETIRIZINE HYDROCHLORIDERUBICON RESEARCHANDA 2203352026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - CETIRIZINE HYDROCHLORIDEREGCON HOLDINGSANDA 2188952024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - CATALENTANDA 2131052020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — - CETIRIZINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2135572020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - QUAGENANDA 2122662019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — - HETERO LABS LTD IIIANDA 2106222019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — - AUROBINDO PHARMA LTDANDA 20910720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — 10MG CAPSULE ORAL OTC — - GRANULESANDA 2092742017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL OTC — - ONESOURCE SPECIALTYANDA 2052912017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL OTC — - APOTEXANDA 2072352016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG CAPSULE ORAL Discontinued — - NOVEL LABS INCANDA 20679320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL OTC — 10MG TABLET, CHEWABLE ORAL OTC — - PERRIGO R AND DANDA 2054902015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL OTC — - AUROBINDO PHARMA LTDANDA 09076020154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - JUBILANT GENERICSANDA 09111620154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL OTC — 10MG TABLET, CHEWABLE ORAL OTC — 5MG TABLET, CHEWABLE ORAL OTC — 10MG TABLET, CHEWABLE ORAL OTC — - AIPING PHARM INCANDA 20227720144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - PERRIGO R AND DANDA 2042262013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — - CIPLA LTDANDA 07731820132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - TRIS PHARMA INCANDA 09057220122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — 5MG/5ML SOLUTION ORAL Discontinued — - CETIRIZINE HYDROCHLORIDECHARTWELL MOLECULARANDA 0788762012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - BAJAJANDA 09132720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - SUN PHARMANDA 09014220114 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL Discontinued — 5MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL Discontinued — - TAROANDA 20154620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - CHARTWELL MOLECULARANDA 09113020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - MARKSANS PHARMAANDA 07893320104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - TORRENT PHARMS LLCANDA 07919120104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - CETIRIZINE HYDROCHLORIDEACTAVIS MID ATLANTICANDA 0786172010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - AUROBINDO PHARMAANDA 09075020102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - AMNEAL PHARMS NYANDA 07878020104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - CETIRIZINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 0907512009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - CETIRIZINE HYDROCHLORIDEBAJAJANDA 0901912009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - CETIRIZINE HYDROCHLORIDEAMNEAL PHARMSANDA 0907662009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - AMNEAL PHARMSANDA 09076520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - CETIRIZINE HYDROCHLORIDELANNETT CO INCANDA 0784962009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - CETIRIZINE HYDROCHLORIDETIME CAP LABSANDA 0787572009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - UNIQUEANDA 07782920094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - TAROANDA 07807220094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - UNICHEMANDA 07868020094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - CETIRIZINE HYDROCHLORIDEAPOZEAL PHARMSANDA 0788702009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - APOZEAL PHARMSANDA 09047420092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - ORBION PHARMSANDA 07886220094 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - CYPRESS PHARMANDA 09030020082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — 5MG/5ML SOLUTION ORAL Discontinued — - CETIRIZINE HYDROCHLORIDEBIONPHARMAANDA 0784882008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - CETIRIZINE HYDROCHLORIDETAROANDA 0766012008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - CETIRIZINE HYDROCHLORIDEPHARM ASSOCANDA 0784122008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - CETIRIZINE HYDROCHLORIDERANBAXY LABS LTDANDA 0774722008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - CETIRIZINE HYDROCHLORIDERSPADAGIS USANDA 0783982008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA - CETIRIZINE HYDROCHLORIDETEVA PHARMSANDA 0772792008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - CHARTWELL RXANDA 09037820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — 5MG/5ML SOLUTION ORAL Discontinued — - RANBAXY LABS LTDANDA 09018320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — 5MG/5ML SOLUTION ORAL Discontinued — - PHARM ASSOCANDA 09018820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — 5MG/5ML SOLUTION ORAL Discontinued — - TAROANDA 09018220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - PERRIGO R AND DANDA 09025420082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL OTC — 5MG/5ML SOLUTION ORAL OTC — - SANDOZANDA 07869220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL OTC — 10MG TABLET, CHEWABLE ORAL OTC — - DR REDDYS LABS LTDANDA 07834320084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — - SUN PHARM INDS INCANDA 07763120084 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL Discontinued — 10MG TABLET, CHEWABLE ORAL Discontinued — 5MG TABLET, CHEWABLE ORAL Discontinued — - GLENMARK PHARMSANDA 07842720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - HERITAGE PHARMAANDA 07861520072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - APOTEX INCANDA 07831720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - CONTRACT PHARMACALANDA 07604720072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - MYLANANDA 07667720074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — - PERRIGO R AND DANDA 07833620074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - PLD ACQUISITIONSANDA 07794620072 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — - SUN PHARM INDS INCANDA 07749920074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - SUN PHARM INDS LTDANDA 07749820074 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC — 5MG TABLET ORAL OTC — 10MG TABLET ORAL OTC —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9180090 | in 3 yr 7 mo | U-2635 | |
| 8513259 | in 3 yr 7 mo | U-2636 | |
| 9119771 | in 3 yr 7 mo | U-2635 | |
| 8314083 | in 3 yr 7 mo | U-2634 | |
| 8263581 | in 3 yr 7 mo | U-2635 | |
| 9993471 | in 3 yr 8 mo | U-1680 | |
| 8829005 | in 3 yr 8 mo | U-1680 | |
| 9750684 | in 3 yr 8 mo | Product | |
| 8829005*PED | in 4 yr 2 mo | ||
| 9254286 | in 6 yr | Product | |
| 9254286*PED | in 6 yr 6 mo |
Approval history
FDA approval span
First approval
30 yr 4 mo ago
Most recent approval
6 mo ago
Approvals span 1996–2026 across 72 FDA applications.
Brand (NDA) 811%
Generic (ANDA) 6489%
Cetirizine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
