Tretinoin

Product NDC: 42291-843
11-digit product format: 422910843
Labeler code: 42291
Product ID: 42291-843_d5ca2438-14cf-74cc-e053-2a95a90a5b16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA201687
Marketing category: ANDA
Marketing start: 2016-09-02
Marketing end: 0000-00-00
Substance: TRETINOIN
Active strength: 10 mg/1
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	42291-843		D	Discontinued by firm		2026-08-03
excluded package	package	42291-843	42291-843-01	D	Discontinued by firm		2026-08-03

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-843-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-843-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-843-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-843-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-843-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-843-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-843-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-843-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-843-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-843-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-843-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-843-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A201687-001	TRETINOIN	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201687-001	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 · 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	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB	RS	2012-10-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201687-001	TRETINOIN	10MG	CAPSULE / ORAL	AB		2012-10-24	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A201687-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201687-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201687-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201687-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201687-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201687-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201687-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201687-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201687-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201687-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201687-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201687-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201687-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201687-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201687-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201687-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201687-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201687-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201687-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201687-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201687-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201687-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201687-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201687-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201687-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201687-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201687-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201687-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201687-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201687-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201687-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201687-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201687-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201687-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201687-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201687-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201687-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201687-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201687-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201687-001	AB	1	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-843-01	EA - Each	42291-843	6210b4bc-b665-4287-a51a-16cd53b23902	1	2016-10-06

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Major Pharmaceuticals	045258e2-5efb-4147-bf74-4c43af04dccc	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687
Tretinoin	TRETINOIN	Par Health USA, LLC	9c4ae9d9-c2a0-4995-a27a-e3f0f0284db9	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687
Tretinoin	TRETINOIN	American Health Packaging	b22d5a07-623a-4645-b87d-a151b86da8d5	2025-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687
Tretinoin	TRETINOIN	Bryant Ranch Prepack	7a7974c7-8b6c-41ae-9a48-a08a1439087a	2024-07-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201687 application number: ANDA201687

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5688UTC01R	TRETINOIN	302-79-4	TRETINOIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-843-01	42291084301	100 CAPSULE in 1 BOTTLE (42291-843-01)	100 capsule	2016-09-02	0000-00-00	No	No	Current