Tretinoin

Product NDC: 68071-3825
Requested package NDC: 68071-3825-2
11-digit product format: 680713825
Labeler code: 68071
Product ID: 68071-3825_31d27deb-e80c-9be7-e063-6294a90a9458
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals, Inc.
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: 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
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
2026-02-19 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
2026-02-19 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Tretinoin
Listing expiration: 2026-12-31

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
31d2794a-ca4b-246a-e063-6394a90a1954	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b80ad7bc-1b6f-7ef4-1ed0-86cd9f459d60	Product name	6	20251124
1426d8f8-b7d5-4053-8554-613df00c0d86	Product name	2	20250616
0e7b8bf1-c46c-4de6-b26a-0c50e34364ec	Product name	2	20250521
e3af9708-3004-7392-4046-5311eaa8bab5	Product name	3	20221128
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
503b047e-e62d-4745-9011-522b13bc701b	Product name	1	20181206
7d41caa2-0b5d-9b03-ab8d-84271de26ef4	Product name	2	20170314
50ca9ff5-82dd-9971-4f2c-5845a76a8572	Product name	2	20150818
0a8118e4-08c6-b395-9ddc-d3e425e0493a	Product name	1	20140508
233bcb0a-cf40-b0a1-b346-c83ac2f43579	Product name	1	20140508
85490a6b-2306-6bf2-c51b-eb63537dc2da	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-3825-2	Tretinoin	20 g in 1 TUBE	CREAM	20		1
68071-3825-2	Tretinoin	1 in 1 CARTON	CREAM	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-3825	TRETINOIN CREAM [NUCARE PHARMACEUTICALS, INC.]	1	Current NDC, 2 package rows	20250406_31d2794a-ca4b-246a-e063-6394a90a1954.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 · 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
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 ndc (package): 68071-3825-2 ndc (product): 68071-3825 ndc11 (package): 68071382502
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106302	tretinoin 0.025 % Topical Cream	PSN	31d2794a-ca4b-246a-e063-6394a90a1954	1
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	31d2794a-ca4b-246a-e063-6394a90a1954	1
106302	tretinoin 0.025 % Topical Cream	SY	31d2794a-ca4b-246a-e063-6394a90a1954	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3825-2	68071382502	1 TUBE in 1 CARTON (68071-3825-2) / 20 g in 1 TUBE	1 tube	2025-04-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tretinoin Cream USP, 0.025%	NuCare Pharmaceuticals, Inc.	2025-04-02	HUMAN PRESCRIPTION DRUG LABEL	1