Application 018642

Type: NDA
Sponsor: ACP NIMBLE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETA-VAL	BETAMETHASONE VALERATE	CREAM;TOPICAL	EQ 0.1% BASE	No	No

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
N018642-001	BETA-VAL	BETAMETHASONE VALERATE	EQ 0.1% BASE	CREAM / TOPICAL	AB		1983-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018642-001	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	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018642-001	BETA-VAL	EQ 0.1% BASE	CREAM / TOPICAL	AB	1983-03-24	`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	N018642-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018642-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018642-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018642-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018642-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018642-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018642-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018642-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018642-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018642-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018642-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018642-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018642-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018642-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018642-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018642-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018642-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018642-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018642-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018642-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018642-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018642-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018642-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018642-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018642-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018642-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018642-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018642-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018642-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018642-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018642-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018642-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018642-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018642-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018642-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018642-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018642-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018642-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018642-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018642-001	AB	1	`e64feba35796…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Valerate	BETAMETHASONE VALERATE	NuCare Pharmaceuticals,Inc.	a2154b33-0f61-49af-e053-2995a90a1810	2024-06-20	Adverse reactions	Exact identifier application applno (NDA): 018642 application number: NDA018642 ndc (product): 68071-5224
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	f8711d17-de6a-45e3-8027-b650308207ed	2023-12-15	Adverse reactions	Exact identifier application applno (NDA): 018642 application number: NDA018642 ndc (product): 50090-4696
Betamethasone Valerate	BETAMETHASONE VALERATE	A-S Medication Solutions	d265d143-343f-41ec-9cb4-18d83edb772b	2023-12-12	Adverse reactions	Exact identifier application applno (NDA): 018642 application number: NDA018642 ndc (product): 50090-3794
Betamethasone Valerate	BETAMETHASONE VALERATE	Cosette Pharmaceuticals, Inc.	784476d2-5e5c-fdba-a677-8973a777b5ef	2022-05-05	Adverse reactions	Exact identifier application applno (NDA): 018642 application number: NDA018642 ndc (product): 0713-0326

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0326	Betamethasone Valerate	Betamethasone Valerate	G&W Laboratories, Inc.	NDA	Current
0713-0326	Betamethasone Valerate	Betamethasone Valerate	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0326	Betamethasone Valerate	Betamethasone Valerate	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0326	Betamethasone Valerate	Betamethasone Valerate	Cosette Pharmaceuticals, Inc.	NDA	Current
50090-3794	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-3794	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-3794	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-3794	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-4696	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-4696	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-4696	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
50090-4696	Betamethasone Valerate	Betamethasone Valerate	A-S Medication Solutions	NDA	Current
68071-2334	Betamethasone Valerate	Betamethasone Valerate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5224	Betamethasone Valerate	Betamethasone Valerate	NuCare Pharmaceuticals,Inc.	NDA	Current
68071-5224	Betamethasone Valerate	Betamethasone Valerate	NuCare Pharmaceuticals,Inc.	NDA	Current
68788-7681	Betamethasone Valerate	Betamethasone Valerate	Preferred Pharmaceuticals, Inc.	NDA	Current
70518-3137	Betamethasone Valerate	Betamethasone Valerate	REMEDYREPACK INC.	NDA	Current
70518-3137	Betamethasone Valerate	Betamethasone Valerate	REMEDYREPACK INC.	NDA	Current