FDA Orange Book · active-ingredient family
Chlorothiazide sodium
Chlorothiazide sodium: 1 brand, 6 generics; first approved Oct 16, 2009; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
6
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- DIURILRLDRISINGNDA 011145—
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (6)
Abbreviated applications
- CHLOROTHIAZIDE SODIUMGLANDANDA 2186302024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - CHLOROTHIAZIDE SODIUMRSSAGENT PHARMS INCANDA 2024622015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - CHLOROTHIAZIDE SODIUMRK PHARMAANDA 2024932014
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Discontinued — - CHLOROTHIAZIDE SODIUMAM REGENTANDA 2025612013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - CHLOROTHIAZIDE SODIUMSUN PHARMANDA 0915462011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP - CHLOROTHIAZIDE SODIUMFRESENIUS KABI USAANDA 0908962009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/VIAL INJECTABLE INJECTION Rx AP
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
17 yr 1 mo ago
Most recent approval
1 yr 11 mo ago
Approvals span 2009–2024 across 7 FDA applications.
Brand (NDA) 114%
Generic (ANDA) 686%
Chlorothiazide sodium: 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.
