Home NDC 46708-623 CLINDAMYCIN PHOSPHATE
Product NDC 46708-623
11-digit product format 467080623
Labeler code 46708
Product ID 46708-623_55359ba6-067b-4e97-8c13-ae3f8dbac818
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name CLINDAMYCIN PHOSPHATE
Dosage form GEL
Route TOPICAL
Labeler Alembic Pharmaceuticals Limited
Application ANDA212466
Marketing category ANDA
Marketing start 2024-04-04
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 A212466-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212466-001 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 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212466-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2024-04-02 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 46708-623-30 CLINDAMYCIN PHOSPHATE 1 in 1 CARTON GEL 1 1 46708-623-30 CLINDAMYCIN PHOSPHATE 30 g in 1 TUBE GEL 30 1 46708-623-60 CLINDAMYCIN PHOSPHATE 1 in 1 CARTON GEL 1 1 46708-623-60 CLINDAMYCIN PHOSPHATE 60 g in 1 TUBE GEL 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 46708-623 CLINDAMYCIN PHOSPHATE GEL [ALEMBIC PHARMACEUTICALS LIMITED] 1 Current NDC, 4 package rows 20250305_41ab7061-7c3a-4a4c-9c44-16851c97ad00.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 46708-623-30 46708062330 1 TUBE in 1 CARTON (46708-623-30) / 30 g in 1 TUBE 1 tube 2024-04-04 No No Current 46708-623-60 46708062360 1 TUBE in 1 CARTON (46708-623-60) / 60 g in 1 TUBE 1 tube 2024-04-04 No No Current