Home NDC 70771-1855 Clindamycin Phosphate
Product NDC 70771-1855
11-digit product format 707711855
Labeler code 70771
Product ID 70771-1855_63bb3224-d5c6-4756-9e39-c6d82edac14d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name clindamycin phosphate
Dosage form GEL
Route TOPICAL
Labeler Zydus Lifesciences Limited
Application ANDA216587
Marketing category ANDA
Marketing start 2023-09-20
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 A216587-001 CLINDAMYCIN PHOSPHATE CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216587-001 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 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216587-001 CLINDAMYCIN PHOSPHATE EQ 1% BASE GEL / TOPICAL AB1 2023-09-19 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 70771-1855-2 Clindamycin Phosphate 30 g in 1 TUBE GEL 30 1 70771-1855-2 Clindamycin Phosphate 1 in 1 CARTON GEL 1 1 70771-1855-3 Clindamycin Phosphate 1 in 1 CARTON GEL 1 1 70771-1855-3 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 70771-1855 CLINDAMYCIN PHOSPHATE GEL [ZYDUS LIFESCIENCES LIMITED] 1 Current NDC, 4 package rows 20230921_ca60af4c-3296-4ef9-839f-9ddb34a266da.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 70771-1855-2 70771185502 1 TUBE in 1 CARTON (70771-1855-2) / 30 g in 1 TUBE 1 tube 2023-09-20 No No Current 70771-1855-3 70771185503 1 TUBE in 1 CARTON (70771-1855-3) / 60 g in 1 TUBE 1 tube 2023-09-20 No No Current