FDA Orange Book
Generic for Cleocin
Cleocin contains clindamycin. 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 Cleocin is clindamycin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT. Generics match 3 of the 4 Cleocin products the Orange Book lists.
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Cleocin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, vaginal | EQ 2% BASE | Marketed (Rx) | AB | 1 | AB |
| cream, vaginal | EQ 2% BASE | Discontinued | None | 1 | AB |
| suppository, vaginal | 100MG | Marketed (Rx) | None | 0 | None |
| swab, topical | EQ 1% BASE | Discontinued | None | 4 | AT |
NDA 050680, 050767, 050537, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic clindamycin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PADAGIS US LLC | 065049 | AT (A-rated, therapeutically equivalent) | May 25, 2000 | EQ 1% BASE |
| FOUGERA PHARMACEUTICALS INC | 065139 | AB (A-rated, therapeutically equivalent) | December 27, 2004 | EQ 2% BASE, EQ 2% BASE |
| EPIC PHARMA LLC | 065513 | AT (A-rated, therapeutically equivalent) | June 17, 2010 | EQ 1% BASE |
| CARNEGIE PHARMACEUTICALS LLC | 219612 | AT (A-rated, therapeutically equivalent) | June 13, 2025 | EQ 1% BASE |
| RISING PHARMA HOLDINGS INC | 218300 | AT (A-rated, therapeutically equivalent) | March 23, 2026 | EQ 1% BASE |
Cleocin NDC codes
Questions
Is there a generic for Cleocin?
Yes. The generic name for Cleocin is clindamycin. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AT. Generics match 3 of the 4 Cleocin products the Orange Book lists.
What is the generic name for Cleocin?
The active ingredient in Cleocin is clindamycin, 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 Cleocin and Clindamycin
- What is Clindamycin used for?FDA label uses
- Is Clindamycin a controlled substance?Federal schedule
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- NDC 0009-3448Cleocin NDC record
- NDC 0009-7667Cleocin NDC record