Home NDC 51672-1394-9 Tretinoin
Product NDC 51672-1394
Requested package NDC 51672-1394-9
11-digit product format 516721394
Labeler code 51672
Product ID 51672-1394_38ef297e-e4cb-0593-e063-6294a90a324d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA211644
Marketing category ANDA
Marketing start 2019-01-25
Substance TRETINOIN
Active strength .5 mg/g
Pharmacologic classes 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 A211644-001 TRETINOIN TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211644-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211644-001 TRETINOIN 0.05% CREAM / TOPICAL AB1 2019-01-25 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tretinoin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRETINOIN .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 106303 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 51672-1394-0 Tretinoin 1 in 1 CARTON CREAM 1 3 51672-1394-0 Tretinoin 20 g in 1 TUBE CREAM 20 3 51672-1394-9 Tretinoin 1 in 1 CARTON CREAM 1 3 51672-1394-9 Tretinoin 45 g in 1 TUBE CREAM 45 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1394 TRETINOIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 2 Current NDC, Legacy NDC, 4 package rows 20190129_2b0c8ee4-83a5-48f1-809a-9716131f7290.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 · 4 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 51672-1394-9 51672139409 1 TUBE in 1 CARTON (51672-1394-9) / 45 g in 1 TUBE 1 tube 2019-01-25 0000-00-00 No No Current