Home NDC 63629-8631 CLINDAMYCIN PHOSPHATE
Product NDC 63629-8631
11-digit product format 636298631
Labeler code 63629
Product ID 63629-8631_00b610eb-ba17-de05-e063-6294a90aa7ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form GEL
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA212104
Marketing category ANDA
Marketing start 2021-01-20
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 A212104-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212104-001 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.
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 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2020-12-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB 2020-12-31 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212104-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2020-12-31 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 63629-8631-1 CLINDAMYCIN PHOSPHATE 60 g in 1 TUBE GEL 60 103 63629-8631-1 CLINDAMYCIN PHOSPHATE 1 in 1 CARTON GEL 1 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-8631 CLINDAMYCIN PHOSPHATE GEL [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 2 package rows 20230718_bdfa283e-87ca-41bd-9ae1-d6652dcfa7dd.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 · 5 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 63629-8631-1 63629863101 1 TUBE in 1 CARTON (63629-8631-1) / 60 g in 1 TUBE 1 tube 2021-01-20 0000-00-00 No No Current