Tretinoin

Product NDC: 68071-3889
11-digit product format: 680713889
Labeler code: 68071
Product ID: 68071-3889_3ded7629-8c3f-6e7a-e063-6294a90a49b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tretinoin
Dosage form: CREAM
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA211645
Marketing category: ANDA
Marketing start: 2019-01-22
Substance: TRETINOIN
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

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
A211645-001	TRETINOIN	TRETINOIN	0.1%	CREAM / TOPICAL	AB		2019-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211645-001	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	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211645-001	TRETINOIN	0.1%	CREAM / TOPICAL	AB	2019-01-22	`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	A211645-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211645-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211645-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211645-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211645-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211645-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211645-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211645-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211645-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211645-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211645-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211645-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211645-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211645-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211645-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211645-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211645-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211645-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211645-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211645-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211645-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211645-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211645-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211645-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211645-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211645-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211645-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211645-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211645-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211645-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211645-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211645-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211645-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211645-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211645-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211645-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211645-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211645-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211645-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211645-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRETINOIN	1 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
198300	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
3ded762b-5fe6-c5ef-e063-6294a90ad602	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
68071-3889-2	Tretinoin	20 g in 1 TUBE	CREAM	20		1
68071-3889-2	Tretinoin	1 in 1 CARTON	CREAM	1		1

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	NuCare Pharmaceuticals,Inc.	3ded762b-5fe6-c5ef-e063-6294a90ad602	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211645 application number: ANDA211645 ndc (product): 68071-3889
Tretinoin	TRETINOIN	A-S Medication Solutions	da206984-4ded-4d5c-8a23-323920466a5f	2025-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211645 application number: ANDA211645
Tretinoin	TRETINOIN	NORTHSTAR RX LLC	de3e7308-1212-4727-b541-568a84dac48a	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211645 application number: ANDA211645
Tretinoin	TRETINOIN	Sun Pharmaceutical Industries, Inc.	9e964be5-8d67-46a8-888e-0351f9113f68	2025-07-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211645 application number: ANDA211645
Tretinoin	TRETINOIN	NuCare Pharmaceuticals, Inc.	31d2cd00-e534-6755-e063-6394a90ab8bb	2025-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211645 application number: ANDA211645

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
198300	tretinoin 0.1 % Topical Cream	PSN	3ded762b-5fe6-c5ef-e063-6294a90ad602	1
198300	tretinoin 1 MG/ML Topical Cream	SCD	3ded762b-5fe6-c5ef-e063-6294a90ad602	1
198300	tretinoin 0.1 % Topical Cream	SY	3ded762b-5fe6-c5ef-e063-6294a90ad602	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68071-3889-2	68071388902	1 TUBE in 1 CARTON (68071-3889-2) / 20 g in 1 TUBE	1 tube	2025-09-03	No	No	Current