Home NDC 68308-685 tazarotene
Product NDC 68308-685
11-digit product format 683080685
Labeler code 68308
Product ID 68308-685_6096a6e0-932a-4eb2-a15a-4fb7b2cd8f67
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tazarotene
Dosage form AEROSOL, FOAM
Route TOPICAL
Labeler Mayne Pharma Inc.
Application NDA202428
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2021-04-23
Substance TAZAROTENE
Active strength 1 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 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 N202428-001 FABIOR TAZAROTENE 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 N202428-001 8808716 2030-02-24 Drug product 2014-08-20
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 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N202428-001 FABIOR 0.1% AEROSOL, FOAM / TOPICAL RLD, RS 2012-05-11 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 115 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202428-001 10688071 2030-02-24 U-2760 Drug product 2020-07-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N202428-001 8808716 2030-02-24 Drug product 2014-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N202428-001 10568859 2030-02-24 U-2760 Drug product 2020-03-25 8072bd15b7f6…
Additional Listing Data#
Finished product Yes
Brand name base tazarotene
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAZAROTENE 1 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 1293451 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 68308-685-50 tazarotene 1 in 1 CARTON AEROSOL, FOAM 1 3 68308-685-50 tazarotene 50 g in 1 CAN AEROSOL, FOAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68308-685 TAZAROTENE AEROSOL, FOAM [MAYNE PHARMA INC.] 3 Current NDC, Legacy NDC, 2 package rows 20240606_0e337598-f589-483f-a2ae-be7c319d7454.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 Marketing end Sample Exclude flag Status 68308-685-50 68308068550 1 CAN in 1 CARTON (68308-685-50) / 50 g in 1 CAN 1 can 2021-04-23 0000-00-00 No No Current