Tazarotene

Product NDC: 68308-745
11-digit product format: 683080745
Labeler code: 68308
Product ID: 68308-745_fa8e7930-3ff4-44d5-8978-0bcabcd6e26f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TAZAROTENE
Dosage form: CREAM
Route: TOPICAL
Labeler: Mayne Pharma
Application: ANDA208662
Marketing category: ANDA
Marketing start: 2021-11-10
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68308-745	68308-745-60	D	Discontinued by firm		2026-08-11

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 · 10 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…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A208662-001	TAZAROTENE	TAZAROTENE	0.1%	CREAM / TOPICAL	AB		2017-12-22
A208662-002	TAZAROTENE	TAZAROTENE	0.05%	CREAM / TOPICAL	AB		2025-03-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A208662-001	AB
A208662-002	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 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208662-002	TAZAROTENE	0.05%	CREAM / TOPICAL	AB	2025-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208662-002	TAZAROTENE	0.05%	CREAM / TOPICAL	AB	2025-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208662-002	TAZAROTENE	0.05%	CREAM / TOPICAL	AB	2025-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208662-002	TAZAROTENE	0.05%	CREAM / TOPICAL	AB	2025-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208662-001	TAZAROTENE	0.1%	CREAM / TOPICAL	AB	2017-12-22	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208662-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208662-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208662-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208662-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208662-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208662-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208662-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208662-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208662-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208662-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208662-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208662-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208662-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208662-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208662-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208662-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208662-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208662-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208662-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208662-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208662-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208662-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208662-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208662-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208662-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208662-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208662-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208662-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208662-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208662-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208662-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208662-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208662-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208662-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208662-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208662-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208662-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208662-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208662-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208662-001	AB	1	`3bdfa0b2c4d7…`

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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0296f0e9-f940-45d9-987e-1ee26a7ca961	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a107c35c-2cb4-4734-a92b-e9ed5cfc34d6	Product name	2	20260220
5993ea1b-833d-fa4b-caad-a0d477537538	Product name	5	20250305
c24b0f4e-b27e-8e2b-a129-1b5a6d72c459	Product name	2	20231128
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
18da2240-e326-4d63-90cd-d6bb15f662a0	Product name	1	20200604
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508
a32b252c-8cd2-cc4a-c64c-4b9d3916df9e	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68308-745-30	GM - Gram	68308-745	c6ff91d4-b5bf-4275-8a6e-73d7ffc6c6d7	1	2021-12-08
68308-745-60	GM - Gram	68308-745	d2505dae-6d4e-438e-a398-c06e653ee9c1	1	2021-12-08

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tazarotene	TAZAROTENE	Cosette Pharmaceuticals, Inc.	fa5caf83-29d5-8229-b125-d7736928f132	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208662 application number: ANDA208662
Tazarotene	TAZAROTENE	Mayne Pharma	0296f0e9-f940-45d9-987e-1ee26a7ca961	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208662 application number: ANDA208662 ndc (product): 68308-745

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
81BDR9Y8PS	TAZAROTENE	118292-40-3	TAZAROTENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68308-745-30	68308074530	1 TUBE in 1 CARTON (68308-745-30) / 30 g in 1 TUBE	1 tube	2021-11-10	0000-00-00	No	No	Current
68308-745-60	68308074560	1 TUBE in 1 CARTON (68308-745-60) > 60 g in 1 TUBE	1 tube	2021-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tazarotene	Mayne Pharma \| Cosette Pharmaceuticals NC Laboratories, LLC	2024-03-05	HUMAN PRESCRIPTION DRUG LABEL	3