Home NDC 51672-1395 Tretinoin
Product NDC 51672-1395
11-digit product format 516721395
Labeler code 51672
Product ID 51672-1395_38ef2970-1212-d2fa-e063-6394a90a7570
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tretinoin
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA211645
Marketing category ANDA
Marketing start 2019-01-22
Substance TRETINOIN
Active strength 1 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 A211645-001 TRETINOIN TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211645-001 AB
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 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211645-001 TRETINOIN 0.1% CREAM / TOPICAL AB 2019-01-22 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 1 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 198300 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 51672-1395-0 Tretinoin 1 in 1 CARTON CREAM 1 4 51672-1395-0 Tretinoin 20 g in 1 TUBE CREAM 20 4 51672-1395-9 Tretinoin 45 g in 1 TUBE CREAM 45 4 51672-1395-9 Tretinoin 1 in 1 CARTON CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-1395 TRETINOIN CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Current NDC, Legacy NDC, 4 package rows 20190126_9e964be5-8d67-46a8-888e-0351f9113f68.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 · 5 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tretinoin TRETINOIN NuCare Pharmaceuticals,Inc. 3ded762b-5fe6-c5ef-e063-6294a90ad602 2025-09-03 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211645 application number: ANDA211645 Tretinoin TRETINOIN A-S Medication Solutions da206984-4ded-4d5c-8a23-323920466a5f 2025-07-23 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211645 application number: ANDA211645 Tretinoin TRETINOIN NORTHSTAR RX LLC de3e7308-1212-4727-b541-568a84dac48a 2025-07-09 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211645 application number: ANDA211645 Tretinoin TRETINOIN Sun Pharmaceutical Industries, Inc. 9e964be5-8d67-46a8-888e-0351f9113f68 2025-07-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211645 application number: ANDA211645 ndc (product): 51672-1395 Tretinoin TRETINOIN NuCare Pharmaceuticals, Inc. 31d2cd00-e534-6755-e063-6394a90ab8bb 2025-04-02 Warnings, Adverse reactions Exact identifier application applno (ANDA): 211645 application number: ANDA211645
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 51672-1395-0 51672139500 1 TUBE in 1 CARTON (51672-1395-0) / 20 g in 1 TUBE 1 tube 2019-01-22 0000-00-00 No No Current 51672-1395-9 51672139509 1 TUBE in 1 CARTON (51672-1395-9) / 45 g in 1 TUBE 1 tube 2019-01-22 0000-00-00 No No Current