FDA Orange Book
Generic for Dolophine Hydrochloride
Dolophine Hydrochloride contains methadone. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Dolophine Hydrochloride is methadone. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 2 of the 3 Dolophine Hydrochloride products the Orange Book lists.
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Dolophine Hydrochloride products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 10MG/30ML | Discontinued | None | 0 | None |
| tablet, oral | 10MG | Discontinued | None | 8 | AA |
| tablet, oral | 5MG | Discontinued | None | 7 | AA |
NDA 006134, held by HIKMA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methadone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 088109 | AA (A-rated, therapeutically equivalent) | March 8, 1983 | 10MG, 5MG |
| SPECGX LLC | 040517 | AA (A-rated, therapeutically equivalent) | April 27, 2004 | 10MG, 5MG |
| THEPHARMANETWORK LLC | 090635 | AA (A-rated, therapeutically equivalent) | November 25, 2009 | 10MG, 5MG |
| EPIC PHARMA LLC | 090065 | AA (A-rated, therapeutically equivalent) | August 18, 2015 | 10MG, 5MG |
| AUROLIFE PHARMA LLC | 203502 | AA (A-rated, therapeutically equivalent) | August 31, 2015 | 10MG, 5MG |
| ELITE LABORATORIES INC | 210484 | AA (A-rated, therapeutically equivalent) | August 2, 2018 | 10MG, 5MG |
| ASCENT PHARMACEUTICALS INC | 211228 | AA (A-rated, therapeutically equivalent) | January 3, 2019 | 10MG, 5MG |
| VISTAPHARM LLC | 204166 | AA (A-rated, therapeutically equivalent) | March 16, 2020 | 10MG |
Questions
Is there a generic for Dolophine Hydrochloride?
Yes. The generic name for Dolophine Hydrochloride is methadone. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 2 of the 3 Dolophine Hydrochloride products the Orange Book lists.
What is the generic name for Dolophine Hydrochloride?
The active ingredient in Dolophine Hydrochloride is methadone, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.