Home NDC 0187-5526 Targretin
Product NDC 0187-5526
11-digit product format 001875526
Labeler code 0187
Product ID 0187-5526_48a80386-cbef-4555-95fe-36bbfafcd760
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bexarotene
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Bausch Health US, LLC
Application NDA021055
Marketing category NDA
Marketing start 1999-12-29
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 N021055-001 TARGRETIN BEXAROTENE 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021055-001 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 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 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 Targretin
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 261349 Internal RxNorm lookup 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 0187-5526-75 Targretin 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 15 0187-5526-75 Targretin 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BEXAROTENE ACTIVE INGREDIENT A61RXM4375 TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 BEXAROTENE ACTIVE MOIETY A61RXM4375 TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 1,4-SORBITAN INACTIVE INGREDIENT AV0YTZ4E6J TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 MANNITOL INACTIVE INGREDIENT 3OWL53L36A TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 POVIDONES INACTIVE INGREDIENT FZ989GH94E TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 SORBITOL INACTIVE INGREDIENT 506T60A25R TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6 WATER INACTIVE INGREDIENT 059QF0KO0R TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [VALEANT PHARMACEUTICALS NORTH AMERICA LLC] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5526 TARGRETIN (BEXAROTENE) CAPSULE, LIQUID FILLED [BAUSCH HEALTH US, LLC] 15 Current NDC, Legacy NDC, 2 package rows 20221208_1d056725-0576-4338-8089-6336e768ccdc.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 0187-5526-75 00187552675 1 BOTTLE in 1 CARTON (0187-5526-75) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 1999-12-29 0000-00-00 No No Current