Ultravate

Product NDC: 10631-122
11-digit product format: 106310122
Labeler code: 10631
Product ID: 10631-122_8afe3d44-b60c-4ba2-ab6c-8da871fc62b0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: halobetasol propionate
Dosage form: LOTION
Route: TOPICAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: NDA208183
Marketing category: NDA
Marketing start: 2016-03-01
Marketing end: 0000-00-00
Substance: HALOBETASOL PROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	10631-122		D	Discontinued by firm	2026-08-11
excluded package	package	10631-122	10631-122-04	D	Discontinued by firm	2026-08-11
excluded package	package	10631-122	10631-122-51	D	Discontinued by firm	2026-08-11
excluded package	package	10631-122	10631-122-70	D	Discontinued by firm	2026-08-11

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10631-122-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10631-122-70	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10631-122-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10631-122-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10631-122-70	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10631-122-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10631-122-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10631-122-70	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10631-122-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10631-122-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10631-122-70	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10631-122-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10631-122-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10631-122-70	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10631-122-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10631-122-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10631-122-70	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10631-122-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10631-122-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10631-122-70	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10631-122-51	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10631-122-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10631-122-70	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10631-122-51	`ed331223b511…`	`672a5bd82f5f…`

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
N208183-001	ULTRAVATE	HALOBETASOL PROPIONATE	0.05%	LOTION / TOPICAL		RLD, RS	2015-11-06

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD	2015-11-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	ULTRAVATE	0.05%	LOTION / TOPICAL	RLD, RS	2015-11-06	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	8962028	2033-06-19	U-1775	Drug product	2015-12-03	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N208183-001	NPP	2023-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N208183-001	NPP	2023-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N208183-001	NPP	2023-08-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N208183-001	NPP	2023-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N208183-001	NPP	2023-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N208183-001	NPP	2023-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N208183-001	NPP	2023-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N208183-001	NPP	2023-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N208183-001	NPP	2023-08-31	`c0c555d07b60…`
2023-12-20 04:57 UTC	2023-12	N208183-001	NPP	2023-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N208183-001	NPP	2023-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N208183-001	NPP	2023-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N208183-001	NPP	2023-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N208183-001	NPP	2023-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N208183-001	NPP	2023-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N208183-001	NPP	2023-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N208183-001	NPP	2023-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N208183-001	NPP	2023-08-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N208183-001	NPP	2023-08-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N208183-001	NPP	2023-08-31	`cb3db0bc1861…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10631-122-04	ML - Milliliter	10631-122	4d4b2c71-68e7-439f-a2f8-01b9263fa8b7	1	2016-05-16
10631-122-51	ML - Milliliter	10631-122	cdadacab-0511-42cb-88ad-e24bdc470e91	1	2018-04-19

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
Halobetasol Propionate	HALOBETASOL PROPIONATE	Coral Way Pharma, LLC	4cb1f7b3-c412-6fc7-e063-6394a90a63c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208183 application number: NDA208183
ULTRAVATE	HALOBETASOL PROPIONATE	Lacer Pharma, LLC	74e899db-1c1f-48b2-9913-5d32a14906ae	2025-04-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 208183 application number: NDA208183

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
91A0K1TY3Z	HALOBETASOL PROPIONATE	66852-54-8	HALOBETASOL PROPIONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10631-122-04	10631012204	59 g in 1 BOTTLE (10631-122-04)	59 g	2016-03-01	0000-00-00	No	No	Current
10631-122-51	10631012251	2 BOTTLE in 1 CARTON (10631-122-51) > 59 g in 1 BOTTLE (10631-122-04)	2 bottle	2018-03-19	0000-00-00	No	No	Current
10631-122-70	10631012270	5 TUBE in 1 CARTON (10631-122-70) > 2 g in 1 TUBE (10631-122-19)	5 tube	2016-04-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ultravate	Sun Pharmaceutical Industries, Inc. \| Ferndale Laboratories, Inc.	2025-01-13	HUMAN PRESCRIPTION DRUG LABEL	6