Home NDC 0713-0805 TAZAROTENE
Product NDC 0713-0805
11-digit product format 007130805
Labeler code 0713
Product ID 0713-0805_0b4ad65c-1d55-3e68-e063-6294a90a8e54
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazarotene
Dosage form GEL
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA215433
Marketing category ANDA
Marketing start 2022-09-14
Substance TAZAROTENE
Active strength .5 mg/g
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 A215433-001 TAZAROTENE TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215433-001 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.
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 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215433-001 TAZAROTENE 0.05% GEL / TOPICAL AB 2022-09-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base TAZAROTENE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAZAROTENE .5 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 81BDR9Y8PS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313199 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 0713-0805-31 TAZAROTENE 30 g in 1 TUBE GEL 30 2 0713-0805-31 TAZAROTENE 1 in 1 CARTON GEL 1 2 0713-0805-99 TAZAROTENE 1 in 1 CARTON GEL 1 2 0713-0805-99 TAZAROTENE 100 g in 1 TUBE GEL 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0713-0805 TAZAROTENE GEL [COSETTE PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 4 package rows 20231130_ecd718fd-c06e-4b3a-8aca-fa51e7c51a66.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 0713-0805-31 00713080531 1 TUBE in 1 CARTON (0713-0805-31) / 30 g in 1 TUBE 1 tube 2022-09-14 0000-00-00 No No Current 0713-0805-99 00713080599 1 TUBE in 1 CARTON (0713-0805-99) / 100 g in 1 TUBE 1 tube 2022-09-14 0000-00-00 No No Current