FDA Orange Book
Generic for Sinemet CR
Sinemet CR contains carbidopa and levodopa. 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 Sinemet CR is carbidopa and levodopa. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sinemet CR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 25MG;100MG | Discontinued | None | 6 | AB |
| tablet, extended release, oral | 50MG;200MG | Discontinued | None | 6 | AB |
NDA 019856, held by ORGANON LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carbidopa and levodopa
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 075091 | AB (A-rated, therapeutically equivalent) | April 21, 2000 | 25MG;100MG, 50MG;200MG |
| IMPAX LABORATORIES INC | 076521 | AB (A-rated, therapeutically equivalent) | May 14, 2004 | 25MG;100MG, 50MG;200MG |
| ACCORD HEALTHCARE INC | 202323 | AB (A-rated, therapeutically equivalent) | February 8, 2013 | 25MG;100MG, 50MG;200MG |
| ALEMBIC PHARMACEUTICALS LTD | 210341 | AB (A-rated, therapeutically equivalent) | June 5, 2019 | 25MG;100MG, 50MG;200MG |
| SCIEGEN PHARMACEUTICALS INC | 214091 | AB (A-rated, therapeutically equivalent) | October 5, 2021 | 25MG;100MG, 50MG;200MG |
| RUBICON RESEARCH LTD | 217482 | AB (A-rated, therapeutically equivalent) | June 4, 2024 | 25MG;100MG, 50MG;200MG |
Questions
Is there a generic for Sinemet CR?
Yes. The generic name for Sinemet CR is carbidopa and levodopa. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Sinemet CR?
The active ingredient in Sinemet CR is carbidopa and levodopa, 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.