Home NDC 10370-268 Tretinoin
Product NDC 10370-268
11-digit product format 103700268
Labeler code 10370
Product ID 10370-268_706a0d15-318d-404c-8a90-efab0237c7ff
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tretinoin
Dosage form CAPSULE
Route ORAL
Labeler Par Health USA, LLC
Application ANDA201687
Marketing category ANDA
Marketing start 2012-10-24
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 10370-268 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 10370-268 10370-268-01 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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 A201687-001 TRETINOIN TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201687-001 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 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB RS 2012-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201687-001 TRETINOIN 10MG CAPSULE / ORAL AB 2012-10-24 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10370-268-01 Tretinoin 100 in 1 BOTTLE CAPSULE 100 17
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRETINOIN ACTIVE INGREDIENT 5688UTC01R TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 TRETINOIN ACTIVE INGREDIENT 5688UTC01R TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 TRETINOIN ACTIVE MOIETY 5688UTC01R TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 TRETINOIN ACTIVE MOIETY 5688UTC01R TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 MEDIUM-CHAIN TRIGLYCERIDES INACTIVE INGREDIENT C9H2L21V7U TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 NITROGEN INACTIVE INGREDIENT N762921K75 TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 NITROGEN INACTIVE INGREDIENT N762921K75 TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V TRETINOIN CAPSULE [AMERICAN HEALTH PACKAGING] 1 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V TRETINOIN CAPSULE [PAR PHARMACEUTICAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10370-268 TRETINOIN CAPSULE [ENDO USA, INC.] 15 Current NDC, Legacy NDC, 1 package rows 20250327_9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tretinoin TRETINOIN Major Pharmaceuticals 045258e2-5efb-4147-bf74-4c43af04dccc 2026-05-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687 Tretinoin TRETINOIN Par Health USA, LLC 9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9 2026-03-10 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687 ndc (product): 10370-268 Tretinoin TRETINOIN American Health Packaging b22d5a07-623a-4645-b87d-a151b86da8d5 2025-10-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687 Tretinoin TRETINOIN Bryant Ranch Prepack 7a7974c7-8b6c-41ae-9a48-a08a1439087a 2024-07-16 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 201687 application number: ANDA201687
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 10370-268-01 10370026801 100 CAPSULE in 1 BOTTLE (10370-268-01) 100 capsule 2012-10-24 0000-00-00 No No Current