FDA Orange Book · active-ingredient family
Tramadol hydrochloride
Tramadol hydrochloride: 6 brands, 35 generics; first approved Mar 03, 1995; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 35 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
6
Generics (ANDA)
35
Listed patents
2
Next patent expiry
Sep 01, 2040
in 14 yr 3 mo
Brand (NDA) products
Originator applications
- QDOLORLDROSEMONTNDA 2140442020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML SOLUTION ORAL Discontinued — - CIPHER PHARMS INCNDA 02237020104 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE, EXTENDED RELEASE ORAL Rx — 200MG CAPSULE, EXTENDED RELEASE ORAL Rx — 300MG CAPSULE, EXTENDED RELEASE ORAL Rx — 150MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - RYZOLTRLDPURDUE PHARMANDA 02174520083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ULTRAM ERRLDVALEANT PHARMSNDA 02169220053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ULTRAMRLDJANSSEN PHARMSNDA 02028119952 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued — - SHIONOGI INCNDA 0216932005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued —
Generic (ANDA) products (35)
Abbreviated applications
- TRAMADOL HYDROCHLORIDERSNOVITIUM PHARMAANDA 2196472026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/ML SOLUTION ORAL Rx — - TRAMADOL HYDROCHLORIDESTRIDES PHARMAANDA 20207520262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 20940420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 300MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - TRAMADOL HYDROCHLORIDERUBICON RESEARCHANDA 20870820234 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB 75MG TABLET ORAL Rx — - TRAMADOL HYDROCHLORIDEUNICHEMANDA 2118252019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDEPURACAP LABS BLUANDA 2067062019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEMYLANANDA 20525720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 20442120153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 2057022015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 2034942014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDEACCORD HLTHCAREANDA 2023902013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDECSPC OUYI PHARM COANDA 0914982013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDEIPCA LABS LTDANDA 2019732012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEACTAVIS ELIZABETHANDA 09160920123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDEPH HEALTHANDA 20049120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDESUN PHARMANDA 09160720113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDESUN PHARMANDA 20138420113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDERSLUPIN LTDANDA 20050320113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Rx AB1 200MG TABLET, EXTENDED RELEASE ORAL Rx AB1 300MG TABLET, EXTENDED RELEASE ORAL Rx AB1 - TRAMADOL HYDROCHLORIDESENORES PHARMSANDA 0904042011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDENORTHSTAR HLTHCAREANDA 0789352010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDESTRIDES PHARMA INTLANDA 07878320093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG TABLET, EXTENDED RELEASE ORAL Discontinued — 200MG TABLET, EXTENDED RELEASE ORAL Discontinued — 300MG TABLET, EXTENDED RELEASE ORAL Discontinued — - TRAMADOL HYDROCHLORIDEMYLAN PHARMS INCANDA 0759802002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEASTAANDA 0759742002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEAPOTEXANDA 0759812002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEIVAX SUB TEVA PHARMSANDA 0759632002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEPLIVAANDA 0759822002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEGRAVITI PHARMSANDA 07596820022 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDESPECGX LLCANDA 0759832002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEWATSON LABSANDA 0759622002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEMYLANANDA 0759862002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEAMNEAL PHARMSANDA 0760032002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDESUN PHARM INDUSTRIESANDA 0761002002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDEACTAVIS ELIZABETHANDA 0759602002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - TRAMADOL HYDROCHLORIDESUN PHARM INDS INCANDA 0759642002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - TRAMADOL HYDROCHLORIDETEVAANDA 0759772002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11103452 | in 14 yr 3 mo | ProductU-3197 | |
| 11752103 | in 14 yr 3 mo | ProductU-3197 |
Approval history
FDA approval span
First approval
31 yr 11 mo ago
Most recent approval
1 mo ago
Approvals span 1995–2026 across 41 FDA applications.
Brand (NDA) 615%
Generic (ANDA) 3585%
Tramadol 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.
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- 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.
