Home NDC 0591-2832 bexarotene
Product NDC 0591-2832
11-digit product format 005912832
Labeler code 0591
Product ID 0591-2832_76dd1532-aa15-4e10-a26f-3cb25fbf8c1f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bexarotene
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA209931
Marketing category ANDA
Marketing start 2021-11-11
Substance BEXAROTENE
Active strength 75 mg/1
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 A209931-001 BEXAROTENE BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209931-001 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 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209931-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2021-01-14 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base bexarotene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEXAROTENE 75 mg/1
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 308725 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 0591-2832-01 bexarotene 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2832 BEXAROTENE CAPSULE, LIQUID FILLED [ACTAVIS PHARMA, INC.] 8 Current NDC, Legacy NDC, 1 package rows 20250205_3292c63c-052f-4f28-b739-530a86e660bf.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 Marketing start Marketing end Sample Exclude flag Status 0591-2832-01 00591283201 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (0591-2832-01) 2021-11-11 0000-00-00 No No Current