FDA Orange Book
Generic for Stalevo
Stalevo contains carbidopa, levodopa and entacapone. 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 Stalevo is carbidopa, levodopa and entacapone. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Stalevo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 12.5MG;200MG;50MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 18.75MG;200MG;75MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 25MG;200MG;100MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 31.25MG;200MG;125MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 37.5MG;200MG;150MG | Marketed (Rx) | AB | 3 | AB |
| tablet, oral | 50MG;200MG;200MG | Marketed (Rx) | AB | 3 | AB |
NDA 021485, held by ORION PHARMA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic carbidopa, levodopa and entacapone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 213212 | AB (A-rated, therapeutically equivalent) | January 25, 2022 | 12.5MG;200MG;50MG, 18.75MG;200MG;75MG, 25MG;200MG;100MG, 31.25MG;200MG;125MG, 37.5MG;200MG;150MG, 50MG;200MG;200MG |
| MACLEODS PHARMACEUTICALS LTD | 214495 | AB (A-rated, therapeutically equivalent) | April 15, 2025 | 12.5MG;200MG;50MG, 18.75MG;200MG;75MG, 25MG;200MG;100MG, 31.25MG;200MG;125MG, 37.5MG;200MG;150MG, 50MG;200MG;200MG |
| ALEMBIC PHARMACEUTICALS LTD | 218535 | AB (A-rated, therapeutically equivalent) | February 5, 2026 | 12.5MG;200MG;50MG, 18.75MG;200MG;75MG, 25MG;200MG;100MG, 31.25MG;200MG;125MG, 37.5MG;200MG;150MG, 50MG;200MG;200MG |
Stalevo NDC codes
Questions
Is there a generic for Stalevo?
Yes. The generic name for Stalevo is carbidopa, levodopa and entacapone. 3 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 Stalevo?
The active ingredient in Stalevo is carbidopa, levodopa and entacapone, 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.