Tretinoin

Product NDC: 67296-2287
11-digit product format: 672962287
Labeler code: 67296
Product ID: 67296-2287_57d1ea64-27fa-70d7-e063-6394a90a06b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Redpharm Drug
Application: ANDA215713
Marketing category: ANDA
Marketing start: 2023-01-05
Substance: TRETINOIN
Active strength: .25 mg/g
Pharmacologic classes: Retinoid [EPC], Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A215713-001	TRETINOIN	TRETINOIN	0.025%	CREAM / TOPICAL	AB		2023-01-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215713-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215713-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	2023-01-05	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215713-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215713-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215713-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215713-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215713-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215713-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215713-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215713-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215713-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215713-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215713-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215713-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215713-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215713-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215713-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215713-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215713-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215713-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215713-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215713-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215713-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215713-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215713-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215713-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215713-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215713-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Tretinoin
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	.25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5688UTC01R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106302	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
57d1e8ed-ffc8-5e19-e063-6294a90af941	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tretinoin	TRETINOIN	Redpharm Drug	57d1e8ed-ffc8-5e19-e063-6294a90af941	2026-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713 ndc (product): 67296-2287
Tretinoin	TRETINOIN	NuCare Pharmaceuticals,Inc.	3deccf35-67ad-9cbc-e063-6394a90a7ee9	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713
Tretinoin	TRETINOIN	Sun Pharmaceutical Industries, Inc.	2a31b13b-5cc8-4f6a-b364-872f6a478025	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713
Tretinoin	TRETINOIN	NORTHSTAR RX LLC	c0212b19-0676-4546-bc5d-682c089e7b7d	2025-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713
Tretinoin	TRETINOIN	Preferred Pharmaceuticals Inc.	fda88f47-21b3-4678-ab21-befb03035730	2025-04-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713
Tretinoin	TRETINOIN	NuCare Pharmaceuticals, Inc.	31d2794a-ca4b-246a-e063-6394a90a1954	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713
Tretinoin	TRETINOIN	A-S Medication Solutions	06ebaf8e-3648-493e-9b6a-9adef67bc65f	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215713 application number: ANDA215713

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	Sample	Exclude flag	Status
67296-2287-4	67296228704	1 TUBE in 1 CARTON (67296-2287-4) / 45 g in 1 TUBE	1 tube	2023-01-05	No	No	Current