FDA Orange Book · active-ingredient family
Methocarbamol
Methocarbamol: 3 brands, 71 generics; first approved Jan 22, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 71 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
71
Listed patents
1
Next patent expiry
Oct 09, 2044
in 18 yr 3 mo
Brand (NDA) products
Originator applications
- ROSEMONT PHARMSNDA 2198432025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG/5ML SUSPENSION ORAL Rx - - HIKMANDA 011790-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - ROBAXINRLDENDO OPERATIONSNDA 011011-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued -
Generic (ANDA) products (71)
Abbreviated applications
- METHOCARBAMOLMIKARTANDA 2127072023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM TABLET ORAL Rx AB - METHOCARBAMOLAUROBINDO PHARMA LTDANDA 21396720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Rx AA 500MG TABLET ORAL Rx AA - METHOCARBAMOLBAXTER HLTHCARE CORPANDA 2150652022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Discontinued - - METHOCARBAMOLRSBOSTALANDA 20095820213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA 1GM TABLET ORAL Rx AB - METHOCARBAMOLPOINTVIEW HLDINGSANDA 21262320212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA - METHOCARBAMOLGLANDANDA 2115042018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLRSGRANULESANDA 20931220182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA - METHOCARBAMOLFRESENIUS KABI USAANDA 2093312018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLNAVINTA LLCANDA 2060712017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Discontinued - - METHOCARBAMOLSOMERSET THERAPS LLCANDA 2075222017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLREGCON HOLDINGSANDA 20850720172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA - METHOCARBAMOLSAGENT PHARMS INCANDA 2054042017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLAM REGENTANDA 2074962017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLHLTHCAREANDA 20355020172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA - METHOCARBAMOLHAINAN POLYANDA 2081162017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLMONTEREY PHARMS LLCANDA 2053542016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLEUGIA PHARMAANDA 2061282016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Rx AP - METHOCARBAMOLPHARMOBEDIENTANDA 2044042014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/10ML (100MG/ML) SOLUTION IM-IV Discontinued - - METHOCARBAMOLHETERO LABS LTD IIIANDA 09020020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA - METHOCARBAMOLCHARTWELL MOLECULARANDA 08475620032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - - METHOCARBAMOLABLEANDA 04041320032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - METHOCARBAMOLOXFORD PHARMSANDA 04048920032 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Rx AA 750MG TABLET ORAL Rx AA - METHOCARBAMOLMARSAM PHARMS LLCANDA 0898491991
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued - - METHOCARBAMOLAM THERAPANDA 0894171987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLAM THERAPANDA 0894181987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLPIONEER PHARMSANDA 0887311985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLPIONEER PHARMSANDA 0890821985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLROXANEANDA 0886461984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLROXANEANDA 0886471984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLASCOTANDA 0876601982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLASCOTANDA 0876611982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLSUPERPHARMANDA 0875891982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLSUPERPHARMANDA 0875901982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLDR REDDYSANDA 086459-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued - - FERNDALE LABSANDA 085454-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - FOREST LABSANDA 085136-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLAIPING PHARM INCANDA 084616-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLAIPING PHARM INCANDA 084615-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLANI PHARMSANDA 084277-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLANI PHARMSANDA 084276-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLCLONMEL HLTHCAREANDA 085961-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLCLONMEL HLTHCAREANDA 085963-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLHEATHERANDA 084675-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLHEATHERANDA 084924-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLHIKMA INTL PHARMSANDA 085123-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - 500MG TABLET ORAL Discontinued - - METHOCARBAMOLIMPAX LABSANDA 084927-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLIMPAX LABSANDA 084928-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLINWOOD LABSANDA 085137-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLIVAX SUB TEVA PHARMSANDA 084648-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLIVAX SUB TEVA PHARMSANDA 084649-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLKV PHARMANDA 085660-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLKV PHARMANDA 085658-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLMYLANANDA 084259-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLMYLANANDA 084323-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLNYLOSANDA 085033-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLPRINSTON INCANDA 086988-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Rx AA 500MG TABLET ORAL Rx AA - METHOCARBAMOLPURACAP PHARMANDA 084231-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLPURACAP PHARMANDA 084471-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLPUREPAC PHARMANDA 085718-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - METHOCARBAMOLSANDOZANDA 087283-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLSANDOZANDA 087282-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLSOLVAYANDA 084448-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLSOLVAYANDA 084449-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLSUN PHARM INDUSTRIESANDA 084488-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLSUN PHARM INDUSTRIESANDA 084486-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLTABLICAPSANDA 084846-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLUPSHER SMITHANDA 087453-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLUPSHER SMITHANDA 087454-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued - - METHOCARBAMOLWATSON LABSANDA 083605-2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - 750MG TABLET ORAL Discontinued - - METHOCARBAMOLWATSON LABSANDA 085180-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG TABLET ORAL Discontinued - - METHOCARBAMOLWATSON LABSANDA 085192-
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG TABLET ORAL Discontinued -
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12390439 | in 18 yr 3 mo | ProductU-4253 |
Approval history
FDA approval span
First approval
45 yr 5 mo ago
Most recent approval
1 yr 3 mo ago
Approvals span 1982–2025 across 74 FDA applications.
Brand (NDA) 34%
Generic (ANDA) 7196%
Methocarbamol: 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.
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