Home NDC 68682-003-10 bexarotene
Product NDC 68682-003
Requested package NDC 68682-003-10
11-digit product format 686820003
Labeler code 68682
Product ID 68682-003_22590cf5-85a5-4129-a313-2e1cb2aba25d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bexarotene
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Oceanside Pharmaceuticals
Application NDA021055
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2015-12-17
Marketing end 0000-00-00
Substance BEXAROTENE
Active strength 75 mg/1
Pharmacologic classes Retinoid [EPC],Retinoids [CS]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…
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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded BEXAROTENE ACTIVE INGREDIENT A61RXM4375 BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 BEXAROTENE ACTIVE MOIETY A61RXM4375 BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 1,4-SORBITAN INACTIVE INGREDIENT AV0YTZ4E6J BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 MANNITOL INACTIVE INGREDIENT 3OWL53L36A BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2 WATER INACTIVE INGREDIENT 059QF0KO0R BEXAROTENE CAPSULE, LIQUID FILLED [OCEANSIDE PHARMACEUTICALS] 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Targretin BEXAROTENE Bausch Health US, LLC 1d056725-0576-4338-8089-6336e768ccdc 2020-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021055 application number: NDA021055
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68682-003-10 68682000310 1 BOTTLE in 1 CARTON (68682-003-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2015-12-17 0000-00-00 No No Current