Home NDC 21922-050 Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
Product NDC 21922-050
11-digit product format 219220050
Labeler code 21922
Product ID 21922-050_854a8cf5-cfcf-4189-af34-e111363266a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
Dosage form GEL
Route TOPICAL
Labeler Encube Ethicals, Inc.
Application ANDA216943
Marketing category ANDA
Marketing start 2023-09-04
Substance CLINDAMYCIN PHOSPHATE; TRETINOIN
Active strength 10; .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 1 .
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 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN CLINDAMYCIN PHOSPHATE; TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216943-001 AB2
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 2026-02-19 14:30 UTC 2026-02 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216943-001 CLINDAMYCIN PHOSPHATE AND TRETINOIN 1.2%;0.025% GEL / TOPICAL AB2 2023-09-01 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025%
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CLINDAMYCIN PHOSPHATE 10 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 21922-050-05 Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 30 g in 1 TUBE GEL 30 3 21922-050-05 Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 1 in 1 CARTON GEL 1 3 21922-050-07 Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 1 in 1 CARTON GEL 1 3 21922-050-07 Clindamycin Phosphate and Tretinoin Gel 1.2%/0.025% 60 g in 1 TUBE GEL 60 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 21922-050 CLINDAMYCIN PHOSPHATE AND TRETINOIN GEL 1.2%/0.025% GEL [ENCUBE ETHICALS PRIVATE LIMITED] 2 Current NDC, 4 package rows 20231229_1f772408-52a3-45b2-b053-8fc78948983c.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 Sample Exclude flag Status 21922-050-05 21922005005 1 TUBE in 1 CARTON (21922-050-05) / 30 g in 1 TUBE 1 tube 2023-09-04 No No Current 21922-050-07 21922005007 1 TUBE in 1 CARTON (21922-050-07) / 60 g in 1 TUBE 1 tube 2023-09-04 No No Current