Home NDC 42291-072 Bexarotene
Product NDC 42291-072
11-digit product format 422910072
Labeler code 42291
Product ID 42291-072_41163fef-69b8-4e09-e063-6294a90ac8ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bexarotene
Dosage form CAPSULE
Route ORAL
Labeler AvKARE
Application ANDA210105
Marketing category ANDA
Marketing start 2023-04-14
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 A210105-001 BEXAROTENE BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210105-001 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 · 42 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 2026-08-18 06:07:40 2026-07 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210105-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2018-09-04 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 42291-072-01 Bexarotene 100 in 1 BOTTLE CAPSULE 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-072 BEXAROTENE CAPSULE [AVKARE] 1 Current NDC, 1 package rows 20230415_f9514265-6e2c-9030-e053-6394a90aa04b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42291-072-01 42291007201 100 CAPSULE in 1 BOTTLE (42291-072-01) 100 capsule 2023-04-14 No No Current