FDA Orange Book
Generic for Hycodan
Hycodan contains hydrocodone and homatropine methylbromide. 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 Hycodan is hydrocodone and homatropine methylbromide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
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Hycodan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| syrup, oral | 1.5MG/5ML;5MG/5ML | Marketed (Rx) | AA | 3 | AA |
| tablet, oral | 1.5MG;5MG | Marketed (Rx) | AA | 2 | AA |
NDA 005213, held by GENUS LIFESCIENCES INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydrocodone and homatropine methylbromide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS MID ATLANTIC LLC | 088017 | AA (A-rated, therapeutically equivalent) | July 5, 1983 | 1.5MG/5ML;5MG/5ML |
| NOVEL LABORATORIES INC | 203535 | AA (A-rated, therapeutically equivalent) | February 13, 2017 | 1.5MG/5ML;5MG/5ML |
| ABHAI LLC | 207487 | AA (A-rated, therapeutically equivalent) | February 21, 2017 | 1.5MG/5ML;5MG/5ML |
| AVANTHI INC | 207176 | AA (A-rated, therapeutically equivalent) | August 7, 2017 | 1.5MG;5MG |
| PHARMAZONE | 220509 | AA (A-rated, therapeutically equivalent) | September 22, 2026 | 1.5MG;5MG |
Hycodan NDC codes
Questions
Is there a generic for Hycodan?
Yes. The generic name for Hycodan is hydrocodone and homatropine methylbromide. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Hycodan?
The active ingredient in Hycodan is hydrocodone and homatropine methylbromide, 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.