Active ingredient
Clindamycin
212 finished FDA listings contain Clindamycin as their only active ingredient; 31 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CLINDAMYCIN, CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN PALMITATE, CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PHOSPHATE
- Dosage forms
- Aerosol, Foam, Capsule, Capsule, Gelatin Coated, Cream, Gel, Granule, For Solution, Injection, Solution, Lotion, Powder, For Solution, Solution, Suppository, Swab
- Routes
- Intramuscular, Intravenous, Oral, Topical, Vaginal
- Manufacturers / labelers
- 68
- Strengths listed
- 1 g/100ml · 1 g/10ml · 10 mg/1 · 10 mg/g · 10 mg/ml · 10 ug/ml · 100 mg/1 · 100 mg/5g · 11.9 mg/ml · 12 mg/ml · 150 mg/1 · 150 mg/ml · 18 mg/ml · 20 mg/g · 300 mg/1 · 300 mg/50ml · 6 mg/ml · 600 mg/50ml · 75 mg/1 · 75 mg/5ml · 900 mg/50ml
- Brand names in FDA listings
- Cleocin, Cleocin Hydrochloride, Cleocin Pediatric, Cleocin Phosphate, Cleocin T, Clindacin, Clindacin Etz, Clindacin P, Clindagel, Clindamycin, Clindamycin In 5 Percent Dextrose, Clindamycin Palmitate Hydrochloride (Pediatric), Clindamycin Phoaphate Topical Solution Usp, 1%, Clindamycin Phoaphate Topical Usp, 1%, Clindamycin Phosphate, Clindesse, Xaciato
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2582
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 050162 | PFIZER | 1970-02-22 | 3 |
| NDA 050441 | PFIZER | 1972-10-02 | 12 |
| NDA 050615 | PFIZER | 1987-01-07 | 1 |
| NDA 050600 | PFIZER | 1989-05-31 | 2 |
| NDA 050680 | PFIZER | 1992-08-11 | 2 |
| ANDA 064050 | PADAGIS US | 1995-11-30 | 7 |
| ANDA 064160 | FOUGERA PHARMS | 2000-01-28 | 1 |
| ANDA 065049 | PADAGIS US | 2000-05-25 | 4 |
| NDA 050782 | BAUSCH | 2000-11-27 | 2 |
| ANDA 065061 | SUN PHARM INDS LTD | 2001-02-02 | 25 |
| ANDA 065067 | FOUGERA PHARMS | 2002-01-31 | 2 |
| ANDA 065194 | EPIC PHARMA LLC | 2004-03-22 | 1 |
| ANDA 065184 | TARO PHARM INDS | 2004-03-31 | 2 |
| ANDA 065139 | FOUGERA PHARMS | 2004-12-27 | 1 |
| ANDA 065243 | CHARTWELL MOLECULAR | 2005-08-12 | 3 |
| ANDA 065442 | AUROBINDO PHARMA | 2009-08-26 | 11 |
| ANDA 090785 | PADAGIS ISRAEL | 2010-03-31 | 4 |
| ANDA 065513 | EPIC PHARMA LLC | 2010-06-17 | 1 |
| ANDA 090108 | SAGENT PHARMS INC | 2011-09-30 | 5 |
| ANDA 201692 | SANDOZ INC | 2012-05-31 | 5 |
| ANDA 201821 | RISING | 2012-08-28 | 3 |
| ANDA 202409 | AUROBINDO PHARMA LTD | 2013-04-30 | 2 |
| NDA 208083 | BAXTER HLTHCARE CORP | 2017-04-20 | 3 |
| ANDA 208084 | BAXTER HLTHCARE CORP | 2017-06-28 | 7 |
| ANDA 209846 | CHARTWELL RX | 2018-02-08 | 2 |
| ANDA 208767 | ZYDUS LIFESCIENCES | 2018-07-16 | 3 |
| ANDA 207402 | MICRO LABS | 2018-11-05 | 27 |
| ANDA 209914 | ENCUBE ETHICALS | 2019-01-28 | 3 |
| ANDA 210004 | TARO | 2020-03-11 | 1 |
| ANDA 211872 | AMVIKA | 2020-07-29 | 1 |
| ANDA 212104 | PADAGIS ISRAEL | 2020-12-31 | 5 |
| ANDA 214251 | GLENMARK PHARMS LTD | 2021-02-10 | 3 |
| ANDA 214604 | PADAGIS ISRAEL | 2021-03-08 | 5 |
| ANDA 212438 | ENCUBE | 2021-03-11 | 3 |
| ANDA 214526 | SUN PHARMA CANADA | 2021-06-28 | 2 |
| ANDA 210778 | GLENMARK PHARMS LTD | 2021-09-20 | 1 |
| ANDA 216957 | GLENMARK PHARMS LTD | 2023-03-10 | 24 |
| ANDA 214401 | HIKMA | 2023-04-05 | 3 |
| ANDA 216587 | ZYDUS LIFESCIENCES | 2023-09-19 | 2 |
| ANDA 212466 | ALEMBIC | 2024-04-02 | 2 |
Showing 40 of 56 applications.
Official labeling on DailyMed
- CLINDAMYCIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 3 · 2026-09-10
- CLINDAMYCIN HYDROCHLORIDE CAPSULE [CARDINAL HEALTH 107, LLC] · version 10 · 2026-08-25
- CLINDAMYCIN PHOSPHATE CREAM [MYLAN PHARMACEUTICALS INC.] · version 22 · 2026-08-11
- CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE TOPICAL) SOLUTION [I3 PHARMACEUTICALS, LLC] · version 2 · 2026-08-07
- CLINDAMYCIN HYDROCHLORIDE CAPSULE [REMEDYREPACK INC.] · version 4 · 2026-08-03
- CLEOCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION CLEOCIN PHOSPHATE (0009-6582) (STANDALONE) (CLINDAMYCIN PHOSPHATE) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC] · version 60 · 2026-07-31
- CLINDAMYCIN PHOSPHATE (CLINDAMYCIN PHOSPHATE GEL USP, 1%) GEL [ENCUBE ETHICALS, INC.] · version 5 · 2026-07-24
- CLINDAMYCIN PHOSPHATE GEL [ALEMBIC PHARMACEUTICALS INC.] · version 5 · 2026-07-24
- CLINDAMYCIN HYDROCHLORIDE CAPSULE [HAWAII REPACK, INC.] · version 1 · 2026-07-22
- CLINDAMYCIN HYDROCHLORIDE CAPSULE [ST. MARY'S MEDICAL PARK PHARMACY] · version 4 · 2026-07-20
- CLINDAMYCIN HYDROCHLORIDE CAPSULE [MAJOR PHARMACEUTICALS] · version 4 · 2026-07-20
- CLINDAMYCIN PHOSPHATE AEROSOL, FOAM [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 4 · 2026-07-15
Showing the 12 most recent of 174 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.