FDA Orange Book
Generic for Rebetol
Rebetol contains ribavirin. 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 Rebetol is ribavirin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Rebetol products the Orange Book lists.
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Rebetol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 200MG | Discontinued | None | 2 | AB |
| capsule, oral | 200MG | Discontinued | None | 2 | AB |
| solution, oral | 40MG/ML | Discontinued | None | 0 | None |
NDA 020903, 021546, held by MERCK SHARP AND DOHME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ribavirin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ZYDUS PHARMACEUTICALS USA INC | 077224 | AB (A-rated, therapeutically equivalent) | October 28, 2005 | 200MG, 200MG |
| AUROBINDO PHARMA LTD | 079117 | AB (A-rated, therapeutically equivalent) | September 17, 2009 | 200MG, 200MG |
Questions
Is there a generic for Rebetol?
Yes. The generic name for Rebetol is ribavirin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Rebetol products the Orange Book lists.
What is the generic name for Rebetol?
The active ingredient in Rebetol is ribavirin, 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.