Home NDC 0378-6955 Bexarotene
Product NDC 0378-6955
11-digit product format 003786955
Labeler code 0378
Product ID 0378-6955_43459ab6-17fd-4c77-b269-4a97780af170
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bexarotene
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA203174
Marketing category ANDA
Marketing start 2015-07-09
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 A203174-001 BEXAROTENE BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A203174-001 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 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203174-001 BEXAROTENE 75MG CAPSULE / ORAL AB 2014-08-12 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 0378-6955-01 Bexarotene 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BEXAROTENE ACTIVE INGREDIENT A61RXM4375 BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 BEXAROTENE ACTIVE MOIETY A61RXM4375 BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-6955 BEXAROTENE CAPSULE, LIQUID FILLED [MYLAN PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 1 package rows 20211218_2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5.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 0378-6955-01 00378695501 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0378-6955-01) 2015-07-09 0000-00-00 No No Current