TRETINOIN

Product NDC: 68788-4069
11-digit product format: 687884069
Labeler code: 68788
Product ID: 68788-4069_d6819051-4748-479e-8b53-c298edcbd410
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA075264
Marketing category: ANDA
Marketing start: 2026-01-28
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 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
A075264-001	TRETINOIN	TRETINOIN	0.025%	CREAM / TOPICAL	AB		1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075264-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075264-001	TRETINOIN	0.025%	CREAM / TOPICAL	AB	1998-12-24	`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	A075264-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075264-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075264-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075264-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075264-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075264-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075264-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075264-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075264-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075264-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075264-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075264-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075264-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075264-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075264-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075264-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075264-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075264-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075264-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075264-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075264-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075264-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075264-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075264-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075264-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075264-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075264-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075264-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075264-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075264-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075264-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075264-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075264-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075264-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075264-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075264-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075264-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075264-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075264-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075264-001	AB	1	`cb3db0bc1861…`

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
d6819051-4748-479e-8b53-c298edcbd410	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
68788-4069-2	TRETINOIN	1 in 1 CARTON	CREAM	1		1
68788-4069-2	TRETINOIN	20 g in 1 TUBE	CREAM	20		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-4069-2	GM - Gram	68788-4069	6b839ffd-b2e9-46d3-9112-7a4c5d04e8c9	1	2026-03-17

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TRETINOIN	TRETINOIN	Preferred Pharmaceuticals Inc.	d6819051-4748-479e-8b53-c298edcbd410	2026-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264 ndc (product): 68788-4069
TRETINOIN	TRETINOIN	NuCare Pharmaceuticals,Inc.	47fc341b-8cff-9d63-e063-6394a90abdfd	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	Bryant Ranch Prepack	5e84c976-d4d6-4d8f-a448-8afb47e2fbff	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	A-S Medication Solutions	0a6722ba-c2e5-4d7a-82ea-bcd6a54033b5	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264
TRETINOIN	TRETINOIN	Padagis US LLC	4889c7f8-37d0-4f1a-9829-bca107806586	2023-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075264 application number: ANDA075264

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	d6819051-4748-479e-8b53-c298edcbd410	1
106302	tretinoin 0.25 MG/ML Topical Cream	SCD	d6819051-4748-479e-8b53-c298edcbd410	1
106302	tretinoin 0.025 % Topical Cream	SY	d6819051-4748-479e-8b53-c298edcbd410	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68788-4069-2	68788406902	1 TUBE in 1 CARTON (68788-4069-2) / 20 g in 1 TUBE	1 tube	2026-01-28	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tretinoin Gel, USP and Tretinoin Cream, USP	Preferred Pharmaceuticals Inc.	2026-01-28	HUMAN PRESCRIPTION DRUG LABEL	1