Home NDC 68462-792 Tretinoin
Product NDC 68462-792
11-digit product format 684620792
Labeler code 68462
Product ID 68462-792_5761f729-3e1f-4fe7-9d5f-cfb652bf1625
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form CAPSULE
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA208279
Marketing category ANDA
Marketing start 2016-12-23
Substance TRETINOIN
Active strength 10 mg/1
Pharmacologic classes Retinoid [EPC], Retinoids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A208279-001 TRETINOIN TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208279-001 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 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208279-001 TRETINOIN 10MG CAPSULE / ORAL AB 2016-12-23 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRETINOIN 10 mg/1
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 199159 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 68462-792-01 Tretinoin 100 in 1 BOTTLE CAPSULE 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-792 TRETINOIN CAPSULE [GLENMARK PHARMACEUTICALS INC., USA] 4 Current NDC, Legacy NDC, 1 package rows 20230425_264138c1-9e5f-45ef-be87-79ca97c989d9.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tretinoin TRETINOIN Glenmark Pharmaceuticals Inc., USA 264138c1-9e5f-45ef-be87-79ca97c989d9 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 208279 application number: ANDA208279 ndc (product): 68462-792
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 68462-792-01 68462079201 100 CAPSULE in 1 BOTTLE (68462-792-01) 100 capsule 2016-12-23 0000-00-00 No No Current