Clobetasol Propionate

Product NDC: 16714-782
Requested package NDC: 16714-782-01
11-digit product format: 167140782
Labeler code: 16714
Product ID: 16714-782_683b22fa-b609-40de-8547-73b9d1120c22
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Clobetasol Propionate
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Northstar Rx LLC
Application: ANDA208933
Marketing category: ANDA
Marketing start: 2018-05-01
Substance: CLOBETASOL PROPIONATE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	16714-782	16714-782-01	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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A208933-001	CLOBETASOL PROPIONATE	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL			2017-03-20

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	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL		2017-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL		2017-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL		2017-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL		2017-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208933-001	CLOBETASOL PROPIONATE	0.05%	OINTMENT / TOPICAL	AB	2017-03-20	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208933-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208933-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208933-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208933-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208933-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208933-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208933-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208933-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208933-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208933-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208933-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208933-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208933-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208933-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208933-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208933-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208933-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208933-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208933-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208933-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208933-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208933-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208933-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208933-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208933-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208933-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208933-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208933-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208933-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208933-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208933-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208933-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208933-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208933-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208933-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208933-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208933-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CLOBETASOL PROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
779619577M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
861448	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
0d0e8e82-2b57-4cc0-a46b-bd08fb581deb	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
16714-782-01	Clobetasol Propionate	15 g in 1 TUBE	OINTMENT	15	3
16714-782-01	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	3
16714-782-02	Clobetasol Propionate	30 g in 1 TUBE	OINTMENT	30	3
16714-782-02	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	3
16714-782-03	Clobetasol Propionate	45 g in 1 TUBE	OINTMENT	45	3
16714-782-03	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	3
16714-782-04	Clobetasol Propionate	1 in 1 CARTON	OINTMENT	1	3
16714-782-04	Clobetasol Propionate	60 g in 1 TUBE	OINTMENT	60	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-782-01	GM - Gram	16714-782	f455fadc-0cc6-4fdd-8094-179f9fbc7e39	1	2018-10-11
16714-782-02	GM - Gram	16714-782	597970a1-3325-42c4-9c69-55564e4556c4	1	2018-10-11
16714-782-03	GM - Gram	16714-782	3bd368b9-c974-4a6e-9a42-c63c779b179e	1	2018-10-11
16714-782-04	GM - Gram	16714-782	247eae81-9d3a-49d1-9204-811569ad480b	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-782	CLOBETASOL PROPIONATE OINTMENT [NORTHSTAR RX LLC]	3	Current NDC, Legacy NDC, 8 package rows	20240626_0d0e8e82-2b57-4cc0-a46b-bd08fb581deb.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clobetasol Propionate	CLOBETASOL PROPIONATE	A-S Medication Solutions	846f1ae1-0a7f-4609-b1a0-c749ffc79ce8	2024-01-02	Adverse reactions	Exact identifier application applno (ANDA): 208933 application number: ANDA208933
Clobetasol Propionate	CLOBETASOL PROPIONATE	Northstar Rx LLC	0d0e8e82-2b57-4cc0-a46b-bd08fb581deb	2021-05-31	Adverse reactions	Exact identifier application applno (ANDA): 208933 application number: ANDA208933 ndc (package): 16714-782-01 ndc (product): 16714-782 ndc11 (package): 16714078201
Clobetasol Propionate	CLOBETASOL PROPIONATE	Glenmark Pharmaceuticals Inc., USA	420deed6-321f-4a2a-9042-1e61636621aa	2020-08-26	Adverse reactions	Exact identifier application applno (ANDA): 208933 application number: ANDA208933

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
861448	clobetasol propionate 0.05 % Topical Ointment	PSN	846f1ae1-0a7f-4609-b1a0-c749ffc79ce8	7
861448	clobetasol propionate 0.0005 MG/MG Topical Ointment	SCD	846f1ae1-0a7f-4609-b1a0-c749ffc79ce8	7
861448	clobetasol propionate 0.05 % Topical Ointment	SY	846f1ae1-0a7f-4609-b1a0-c749ffc79ce8	7
861448	clobetasol propionate 0.05 % Topical Ointment	PSN	0d0e8e82-2b57-4cc0-a46b-bd08fb581deb	3
861448	clobetasol propionate 0.0005 MG/MG Topical Ointment	SCD	0d0e8e82-2b57-4cc0-a46b-bd08fb581deb	3
861448	clobetasol propionate 0.05 % Topical Ointment	SY	0d0e8e82-2b57-4cc0-a46b-bd08fb581deb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-782-01	16714078201	1 TUBE in 1 CARTON (16714-782-01) > 15 g in 1 TUBE	1 tube	2018-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Clobetasol Propionate Ointment USP, 0.05%	A-S Medication Solutions	2024-01-02	HUMAN PRESCRIPTION DRUG LABEL	7
Clobetasol Propionate Ointment USP, 0.05%	Northstar Rx LLC \| Glenmark Pharmaceuticals Limited	2021-05-31	HUMAN PRESCRIPTION DRUG LABEL	3