Home NDC 0472-1790 Clindamycin Phosphate and Tretinoin
Product NDC 0472-1790
11-digit product format 004721790
Labeler code 0472
Product ID 0472-1790_8d92b9da-5fea-4457-a757-a589d443fd7a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate and Tretinoin
Dosage form GEL
Route TOPICAL
Labeler Actavis Pharma, Inc.
Application ANDA202564
Marketing category ANDA
Marketing start 2016-07-05
Substance CLINDAMYCIN PHOSPHATE; TRETINOIN
Active strength 12; .25 mg/g; mg/g
Pharmacologic classes Decreased Sebaceous Gland Activity [PE], Lincosamide Antibacterial [EPC], Lincosamides [CS], Neuromuscular Blockade [PE], Retinoid [EPC], Retinoids [CS]
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 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202564-001 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 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB 2015-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202564-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB1 2015-06-12 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 and Tretinoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 12 mg/g TRETINOIN .25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination EH6D7113I8 Internal UNII lookup 5688UTC01R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 882548 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 0472-1790-30 Clindamycin Phosphate and Tretinoin 1 in 1 CARTON GEL 1 13 0472-1790-30 Clindamycin Phosphate and Tretinoin 30 g in 1 TUBE GEL 30 13 0472-1790-60 Clindamycin Phosphate and Tretinoin 1 in 1 CARTON GEL 1 13 0472-1790-60 Clindamycin Phosphate and Tretinoin 60 g in 1 TUBE GEL 60 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0472-1790 CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL [ACTAVIS PHARMA, INC.] 13 Current NDC, Legacy NDC, 4 package rows 20240314_79e1c8f6-59cd-4efa-9efa-0762d4b1a10c.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 0472-1790-30 00472179030 1 TUBE in 1 CARTON (0472-1790-30) / 30 g in 1 TUBE 1 tube 2016-07-05 0000-00-00 No No Current 0472-1790-60 00472179060 1 TUBE in 1 CARTON (0472-1790-60) / 60 g in 1 TUBE 1 tube 2016-07-05 0000-00-00 No No Current