Home NDC 72162-2420 TAZAROTENE
Product NDC 72162-2420
11-digit product format 721622420
Labeler code 72162
Product ID 72162-2420_8ce2c2d8-c335-4873-9394-79896d98a8aa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazarotene
Dosage form CREAM
Route TOPICAL
Labeler Bryant Ranch Prepack
Application ANDA217075
Marketing category ANDA
Marketing start 2024-09-09
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 A217075-001 TAZAROTENE TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217075-001 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 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217075-001 TAZAROTENE 0.05% CREAM / TOPICAL AB 2024-07-15 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217075-001 CGT 2025-03-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217075-001 CGT 2025-03-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217075-001 CGT 2025-03-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217075-001 CGT 2025-03-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217075-001 CGT 2025-03-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217075-001 CGT 2025-03-08 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217075-001 CGT 2025-03-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217075-001 CGT 2025-03-08 d06236e962d9…
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 314268 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72162-2420 TAZAROTENE CREAM [BRYANT RANCH PREPACK] 100 Current NDC, 4 package rows 20241113_91264c0a-223c-47b7-b537-071944f25790.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72162-2420-3 72162242003 1 TUBE in 1 CARTON (72162-2420-3) / 30 g in 1 TUBE 1 tube 2024-11-11 No No Current 72162-2420-6 72162242006 1 TUBE in 1 CARTON (72162-2420-6) / 60 g in 1 TUBE 1 tube 2024-11-11 No No Current