Home NDC 69238-2088 Bexarotene
Product NDC 69238-2088
11-digit product format 692382088
Labeler code 69238
Product ID 69238-2088_e90bb84a-0b45-4163-92da-d8ed239a0b1d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bexarotene
Dosage form GEL
Route TOPICAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA215398
Marketing category ANDA
Marketing start 2022-05-04
Substance BEXAROTENE
Active strength 10 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 42 .
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 A215398-001 BEXAROTENE BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215398-001 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.
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 2026-08-18 06:07:40 2026-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215398-001 CGT 2022-11-13 5c6f7cd8ea54…2023-01-26 05:58 UTC 2023-01 A215398-001 CGT 2022-11-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215398-001 CGT 2022-11-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215398-001 CGT 2022-11-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215398-001 CGT 2022-11-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215398-001 CGT 2022-11-13 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Bexarotene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEXAROTENE 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination A61RXM4375 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308724 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 69238-2088-6 Bexarotene 60 g in 1 TUBE GEL 60 7 69238-2088-6 Bexarotene 1 in 1 CARTON GEL 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-2088 BEXAROTENE GEL [AMNEAL PHARMACEUTICALS NY LLC] 7 Current NDC, Legacy NDC, 2 package rows 20231230_2c21f361-e3d1-45a5-a6e7-df8164e3f90d.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 Marketing end Sample Exclude flag Status 69238-2088-6 69238208806 1 TUBE in 1 CARTON (69238-2088-6) / 60 g in 1 TUBE 1 tube 2022-05-04 0000-00-00 No No Current