FDA Orange Book · active-ingredient family
Methadone hydrochloride
Methadone hydrochloride: 6 brands, 28 generics; first approved Aug 30, 1982; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 28 ANDA applications approved.
Brands (NDA)
6
Generics (ANDA)
28
Listed patents
0
Presentations
53
Brand (NDA) products
Originator applications
- SPECGX LLCNDA 017116—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Rx AA - METHADONE HYDROCHLORIDERLDRSMYLAN INSTITUTIONALNDA 021624—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - HIKMANDA 006134—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG/30ML SYRUP ORAL Discontinued — 10MG TABLET ORAL Discontinued — - METHADONE HYDROCHLORIDERLDRSHIKMANDA 017058—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, FOR SUSPENSION ORAL Rx AA - METHADONE HYDROCHLORIDEMALLINCKRODT INCNDA 006383—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50GM/BOT POWDER FOR RX COMPOUNDING Discontinued — 100GM/BOT POWDER FOR RX COMPOUNDING Discontinued — 500GM/BOT POWDER FOR RX COMPOUNDING Discontinued — - SANDOZNDA 017108—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG TABLET, DISPERSIBLE ORAL Discontinued — 5MG TABLET, EFFERVESCENT ORAL Discontinued — 10MG TABLET, EFFERVESCENT ORAL Discontinued — 40MG TABLET, EFFERVESCENT ORAL Discontinued —
Generic (ANDA) products (28)
Abbreviated applications
- METHADONE HYDROCHLORIDEHIKMAANDA 2186092025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - METHADONE HYDROCHLORIDEBRECKENRIDGEANDA 2182522024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - METHADONE HYDROCHLORIDELANNETT CO INCANDA 2120942021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Discontinued — - METHADONE HYDROCHLORIDELANNETT CO INCANDA 2120932020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Rx AA - METHADONE HYDROCHLORIDETHEPHARMANETWORK LLCANDA 09063520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 2041662020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDESPECGX LLCANDA 20753720192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA 10MG/5ML SOLUTION ORAL Rx AA - METHADONE HYDROCHLORIDESPECGX LLCANDA 2073682019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Rx AA - METHADONE HYDROCHLORIDEASCENT PHARMS INCANDA 21122820192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDEELITE LABS INCANDA 21048420182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDESUN PHARM INDUSTRIESANDA 20830520182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - METHADONE HYDROCHLORIDELONG GROVE PHARMSANDA 2083062017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML INJECTABLE INJECTION Rx AP - METHADONE HYDROCHLORIDEAUROLIFE PHARMA LLCANDA 20350220152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDEEPIC PHARMA LLCANDA 09006520152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 09070720102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA 10MG/5ML SOLUTION ORAL Discontinued — - METHADONE HYDROCHLORIDESPECGX LLCANDA 0771422005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, FOR SUSPENSION ORAL Rx AA - METHADONE HYDROCHLORIDERSSPECGX LLCANDA 04051720042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AA 10MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 04024119982 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - METHADONE HYDROCHLORIDEHIKMAANDA 0401801998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Rx AA - METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 0750821998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, FOR SUSPENSION ORAL Rx AA - METHADONE HYDROCHLORIDEROXANEANDA 0740811995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET ORAL Discontinued — - METHADONE HYDROCHLORIDEVISTAPHARM LLCANDA 0400881994
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Rx AA - SPECGX LLCANDA 0741841993
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG TABLET, FOR SUSPENSION ORAL Rx AA - SPECGX LLCANDA 04005019932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - HIKMAANDA 0898971988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML CONCENTRATE ORAL Rx AA - METHADONE HYDROCHLORIDEHIKMAANDA 08810919832 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AA 5MG TABLET ORAL Rx AA - METHADONE HYDROCHLORIDERLDRSHIKMAANDA 0879971982
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/5ML SOLUTION ORAL Rx AA - METHADONE HYDROCHLORIDERLDRSHIKMAANDA 087393—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Rx AA
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
44 yr 9 mo ago
Most recent approval
1 yr 5 mo ago
Approvals span 1982–2025 across 34 FDA applications.
Brand (NDA) 618%
Generic (ANDA) 2882%
Methadone 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.
