Home NDC 59762-3743 clindamycin phosphate
Product NDC 59762-3743
11-digit product format 597623743
Labeler code 59762
Product ID 59762-3743_d4cce371-d34f-42f1-8cd4-0f154115db84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form GEL
Route TOPICAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA050615
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1987-01-07
Substance CLINDAMYCIN PHOSPHATE
Active strength 10 mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N050615-001 CLEOCIN T CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050615-001 AB1
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB RLD, RS 1987-01-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050615-001 CLEOCIN T EQ 1% BASE GEL / TOPICAL AB1 RLD, RS 1987-01-07 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base clindamycin phosphate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197519 Internal RxNorm lookup 309333 Internal RxNorm lookup 2676585 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-3743-1 clindamycin phosphate 30 g in 1 TUBE GEL 30 25 59762-3743-1 clindamycin phosphate 1 in 1 CARTON GEL 1 25 59762-3743-2 clindamycin phosphate 60 g in 1 TUBE GEL 60 25 59762-3743-2 clindamycin phosphate 1 in 1 CARTON GEL 1 25
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-3743 CLINDAMYCIN PHOSPHATE SOLUTION CLINDAMYCIN PHOSPHATE LOTION CLINDAMYCIN PHOSPHATE GEL [MYLAN PHARMACEUTICALS INC.] 24 Current NDC, Legacy NDC, 4 package rows 20250529_f7480256-8b32-419a-8983-e2c413040dba.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 59762-3743-1 59762374301 1 TUBE in 1 CARTON (59762-3743-1) / 30 g in 1 TUBE 1 tube 1987-01-07 0000-00-00 No No Current 59762-3743-2 59762374302 1 TUBE in 1 CARTON (59762-3743-2) / 60 g in 1 TUBE 1 tube 1987-01-07 0000-00-00 No No Current