ADAPALENE

Product NDC: 71589-008
11-digit product format: 715890008
Labeler code: 71589
Product ID: 71589-008_f8a0591d-7337-479f-ad53-3835a9b8fb55
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ADAPALENE
Dosage form: GEL
Route: TOPICAL
Labeler: Aleor Dermaceuticals Limited
Application: ANDA213508
Marketing category: ANDA
Marketing start: 2020-06-26
Marketing end: 0000-00-00
Substance: ADAPALENE
Active strength: 3 mg/g
Pharmacologic classes: Retinoid [EPC],Retinoids [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71589-008		D	Discontinued by firm	2026-08-17
excluded package	package	71589-008	71589-008-15	D	Discontinued by firm	2026-08-17
excluded package	package	71589-008	71589-008-45	D	Discontinued by firm	2026-08-17
excluded package	package	71589-008	71589-008-46	D	Discontinued by firm	2026-08-17

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 · 60 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71589-008-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71589-008-45	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71589-008-46	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71589-008-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71589-008-45	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71589-008-46	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71589-008-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71589-008-45	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71589-008-46	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71589-008-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71589-008-45	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71589-008-46	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71589-008-15	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71589-008-45	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71589-008-46	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71589-008-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71589-008-45	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71589-008-46	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71589-008-46	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71589-008-45	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71589-008-15	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71589-008-46	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71589-008-45	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71589-008-15	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71589-008-46	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71589-008-45	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71589-008-15	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71589-008-46	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71589-008-45	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	71589-008-15	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71589-008-46	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71589-008-45	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	71589-008-15	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71589-008-46	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71589-008-45	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	71589-008-15	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71589-008-46	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71589-008-45	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	71589-008-15	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71589-008-46	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71589-008-45	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71589-008-15	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71589-008-46	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71589-008-45	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71589-008-15	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A213508-001	ADAPALENE	ADAPALENE	0.3%	GEL / TOPICAL	AB		2020-06-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213508-001	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
2026-08-18 06:07:40	2026-07	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213508-001	ADAPALENE	0.3%	GEL / TOPICAL	AB	2020-06-18	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A213508-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213508-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213508-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213508-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213508-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213508-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213508-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213508-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213508-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213508-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213508-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213508-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213508-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213508-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213508-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213508-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213508-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213508-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213508-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213508-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213508-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213508-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213508-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213508-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213508-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213508-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213508-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213508-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213508-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213508-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213508-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213508-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213508-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213508-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213508-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213508-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213508-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213508-001	AB	1	`a50c72e98297…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71589-008-15	2025-03-05	These highlights do not include all the information needed to use ADAPALENE GEL safely and effectively. See full prescribing information for ADAPALENE GEL. ADAPALENE gel, for topical use Initial U.S. Approval: 1996
71589-008-45	2025-03-05	These highlights do not include all the information needed to use ADAPALENE GEL safely and effectively. See full prescribing information for ADAPALENE GEL. ADAPALENE gel, for topical use Initial U.S. Approval: 1996
71589-008-46	2025-03-05	These highlights do not include all the information needed to use ADAPALENE GEL safely and effectively. See full prescribing information for ADAPALENE GEL. ADAPALENE gel, for topical use Initial U.S. Approval: 1996
71589-008-15	2023-01-30	These highlights do not include all the information needed to use ADAPALENE GEL safely and effectively. See full prescribing information for ADAPALENE GEL. ADAPALENE gel, for topical use Initial U.S. Approval: 1996
71589-008-45	2023-01-30	These highlights do not include all the information needed to use ADAPALENE GEL safely and effectively. See full prescribing information for ADAPALENE GEL. ADAPALENE gel, for topical use Initial U.S. Approval: 1996
71589-008-46	2023-01-30	These highlights do not include all the information needed to use ADAPALENE GEL safely and effectively. See full prescribing information for ADAPALENE GEL. ADAPALENE gel, for topical use Initial U.S. Approval: 1996

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ADAPALENE	ADAPALENE	Alembic Pharmaceuticals Limited	5dd6d825-f7c4-4a86-82cc-fcbb41df8542	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213508 application number: ANDA213508
ADAPALENE	ADAPALENE	Alembic Pharmaceuticals Inc.	a3b6f3c3-d615-4b00-a76f-134b75e30a50	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213508 application number: ANDA213508

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1L4806J2QF	ADAPALENE	106685-40-9	ADAPALENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71589-008-15	71589000815	1 TUBE in 1 CARTON (71589-008-15) > 15 g in 1 TUBE	1 tube	2020-06-26	0000-00-00	No	No	Current
71589-008-45	71589000845	1 TUBE in 1 CARTON (71589-008-45) > 45 g in 1 TUBE	1 tube	2020-06-26	0000-00-00	No	No	Current
71589-008-46	71589000846	1 BOTTLE, PUMP in 1 CARTON (71589-008-46) > 45 g in 1 BOTTLE, PUMP		2020-06-26	0000-00-00	No	No	Current