CLOBETASOL PROPIONATE

Product NDC: 61919-329
11-digit product format: 619190329
Labeler code: 61919
Product ID: 61919-329_a8eb8a82-e2ef-4b86-9bd1-e99bd945c0ed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: clobetasol propionate gel
Dosage form: GEL
Route: TOPICAL
Labeler: Direct RX
Application: ANDA075027
Marketing category: ANDA
Marketing start: 2015-01-01
Marketing end: 0000-00-00
Substance: CLOBETASOL PROPIONATE
Active strength: 0 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-329		I	Inactivated by FDA		2026-08-17
excluded package	package	61919-329	61919-329-15	I	Inactivated by FDA		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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-329-15	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-329-15	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-329-15	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-329-15	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-329-15	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-329-15	I	Inactivated by FDA	`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	61919-329-15	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	61919-329-15	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	61919-329-15	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	61919-329-15	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	61919-329-15	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	61919-329-15	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	61919-329-15	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	61919-329-15	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	61919-329-15	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-329-15	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-329-15	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-329-15	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-329-15	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-329-15	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-329-15	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-329-15	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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
A075027-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB		1997-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075027-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075027-001	CLOBETASOL PROPIONATE	0.05%	GEL / TOPICAL	AB	1997-10-31	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075027-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075027-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075027-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075027-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075027-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075027-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075027-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075027-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075027-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075027-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075027-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075027-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075027-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075027-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075027-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075027-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075027-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075027-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075027-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075027-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075027-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075027-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075027-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075027-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075027-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075027-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075027-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075027-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075027-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075027-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075027-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075027-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075027-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075027-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075027-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075027-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075027-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075027-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075027-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075027-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
20abe2c3-3e80-d2b2-39eb-3156e4af4799	Product name	3	20250124
45ad92f8-d116-4c0c-851c-2e740b7d8e6f	Product name	1	20250122
42be0ad5-6fd7-4f1b-8108-6d9dd7d571df	Product name	7	20250107
3813b789-94b9-edd6-f010-6b926dd462e5	Product name	5	20230113
30eee8a1-850e-41ed-b5ab-761301aeab49	Product name	6	20221206
18e5b6f7-c414-b1f1-b684-17fdd02c215e	Product name	4	20210927
1c87bbde-dd91-a122-db33-67ae814cb645	Product name	7	20210510
519b5875-7d7d-4aa6-9d3d-470fa1376595	Product name	4	20200227
98669154-3e9c-47da-8a2c-656ab71848be	Product name	2	20180607
8d4f8539-436f-453b-8b76-5322d403fc8e	Product name	1	20180131
837ac3c6-ee71-c5a6-6eba-c4065f37e9f5	Product name	2	20171010

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-329-15	2020-01-31	C162847	48780-1	9d75b9d0-9f28-f424-e053-dadaa90a57ce	CLOBETASOL PROPIONATE- clobetasol propionate gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-329-15	CLOBETASOL PROPIONATE	15 g in 1 TUBE	GEL	15		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CLOBETASOL PROPIONATE	ACTIVE INGREDIENT	779619577M	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1
CLOBETASOL	ACTIVE MOIETY	ADN79D536H	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-329	CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE GEL) GEL [DIRECT RX]	1	Legacy NDC, 1 package rows	20150623_bb24bbe8-7522-4e99-ac42-bd3079e51107.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	f0ca99cd-6c54-44f8-a9b3-432e93fc5d59	2025-10-08	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	1bdc1978-00d1-43f4-a127-a9d9c709644d	2024-10-30	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	bc021c6c-43db-469c-b1c3-0166b18daea4	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Bryant Ranch Prepack	695b2b8a-9d8c-4e94-bc78-2f535b8e2cbc	2023-07-17	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027
Clobetasol Propionate	CLOBETASOL PROPIONATE	Padagis Israel Pharmaceuticals Ltd	f9df643a-015d-4101-ac8f-c1e05b052df5	2023-03-01	Adverse reactions	Exact identifier application applno (ANDA): 075027 application number: ANDA075027

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
779619577M	CLOBETASOL PROPIONATE	25122-46-7	CLOBETASOL PROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861434	clobetasol propionate 0.05 % Topical Gel	PSN	bb24bbe8-7522-4e99-ac42-bd3079e51107	1
861434	clobetasol propionate 0.0005 MG/MG Topical Gel	SCD	bb24bbe8-7522-4e99-ac42-bd3079e51107	1
861434	clobetasol propionate 0.05 % Topical Gel	SY	bb24bbe8-7522-4e99-ac42-bd3079e51107	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
61919-329-15	61919032915	15 g in 1 TUBE	15 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CLOBETASOL PROPIONATE- clobetasol propionate gel	Direct RX	2015-06-23	HUMAN PRESCRIPTION DRUG LABEL	1