FDA Orange Book
Generic for Sinemet
Sinemet 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 is carbidopa and levodopa. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sinemet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG;100MG | Marketed (Rx) | AB | 7 | AB |
| tablet, oral | 25MG;100MG | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | 25MG;250MG | Marketed (Rx) | AB | 7 | AB |
NDA 017555, held by ORGANON LLC A SUB OF ORGANON AND CO. 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 |
|---|---|---|---|---|
| DR REDDYS LABORATORIES SA | 073618 | AB (A-rated, therapeutically equivalent) | August 28, 1992 | 10MG;100MG |
| DR REDDYS LABORATORIES SA | 073589 | AB (A-rated, therapeutically equivalent) | August 28, 1992 | 25MG;100MG |
| DR REDDYS LABORATORIES SA | 073607 | AB (A-rated, therapeutically equivalent) | August 28, 1992 | 25MG;250MG |
| ACTAVIS ELIZABETH LLC | 074260 | AB (A-rated, therapeutically equivalent) | September 3, 1993 | 10MG;100MG, 25MG;100MG, 25MG;250MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 078536 | AB (A-rated, therapeutically equivalent) | October 28, 2008 | 10MG;100MG, 25MG;100MG, 25MG;250MG |
| PHARMOBEDIENT CONSULTING LLC | 090324 | AB (A-rated, therapeutically equivalent) | September 28, 2009 | 25MG;100MG |
| SCIEGEN PHARMACEUTICALS INC | 214092 | AB (A-rated, therapeutically equivalent) | May 7, 2021 | 10MG;100MG, 25MG;100MG, 25MG;250MG |
| RUBICON RESEARCH LTD | 216505 | AB (A-rated, therapeutically equivalent) | September 21, 2022 | 10MG;100MG, 25MG;100MG, 25MG;250MG |
| AUROBINDO PHARMA LTD | 216537 | AB (A-rated, therapeutically equivalent) | November 28, 2022 | 10MG;100MG, 25MG;100MG, 25MG;250MG |
| ASCENT PHARMACEUTICALS INC | 218939 | AB (A-rated, therapeutically equivalent) | January 14, 2025 | 10MG;100MG, 25MG;100MG, 25MG;250MG |
Sinemet NDC codes
Questions
Is there a generic for Sinemet?
Yes. The generic name for Sinemet is carbidopa and levodopa. 8 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?
The active ingredient in Sinemet 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.
More on Sinemet and Carbidopa and Levodopa
- What is Carbidopa and Levodopa used for?FDA label uses
- Is Carbidopa and Levodopa a controlled substance?Federal schedule
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- Sinemet Medicare Part D coverageBy plan and state
- NDC 78206-166Sinemet NDC record
- NDC 78206-190Sinemet NDC record