Home NDC 0187-5525-60 Targretin
Product NDC 0187-5525
Requested package NDC 0187-5525-60
11-digit product format 001875525
Labeler code 0187
Product ID 0187-5525_0b3ebeef-832b-420e-8d6e-e48b2fc494c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bexarotene
Dosage form GEL
Route TOPICAL
Labeler Bausch Health US, LLC
Application NDA021056
Marketing category NDA
Marketing start 2000-06-28
Substance BEXAROTENE
Active strength 1 g/100g
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 1 .
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 N021056-001 TARGRETIN BEXAROTENE 1% GEL / TOPICAL AB RLD, RS 2000-06-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021056-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021056-001 TARGRETIN 1% GEL / TOPICAL RLD, RS 2000-06-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021056-001 TARGRETIN 1% GEL / TOPICAL AB RLD, RS 2000-06-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Targretin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BEXAROTENE 1 g/100g
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 308724 Internal RxNorm lookup 991233 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 0187-5525-60 Targretin 60 g in 1 TUBE GEL 60 11 0187-5525-60 Targretin 1 in 1 CARTON GEL 1 11
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0187-5525 TARGRETIN (BEXAROTENE) GEL [BAUSCH HEALTH US, LLC] 11 Current NDC, Legacy NDC, 2 package rows 20220823_d35b4697-3f3b-4aa1-b5d9-153993e83811.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 0187-5525-60 00187552560 1 TUBE in 1 CARTON (0187-5525-60) / 60 g in 1 TUBE 1 tube 2000-06-28 0000-00-00 No No Current