Application 076543

Type: ANDA
Sponsor: TARO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	CREAM, AUGMENTED;TOPICAL	EQ 0.05% 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
A076543-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2003-12-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076543-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2003-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2003-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2003-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	RS	2003-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076543-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		2003-12-09	`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	A076543-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076543-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076543-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076543-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076543-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076543-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076543-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076543-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076543-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076543-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076543-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076543-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076543-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076543-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076543-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076543-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076543-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076543-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076543-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076543-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076543-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076543-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076543-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076543-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076543-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076543-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076543-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076543-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076543-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076543-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076543-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076543-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076543-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076543-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076543-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076543-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076543-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076543-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076543-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076543-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Preferred Pharmaceuticals, Inc.	54eff1fc-c611-4929-bb44-c1834c08f506	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076543 application number: ANDA076543 ndc (product): 68788-7670
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	abd5a08c-4bb7-46c9-9e2e-0a89c43d46c8	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076543 application number: ANDA076543 ndc (product): 50090-5232
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Sun Pharmaceutical Industries, Inc.	000ae256-a337-4903-845b-003777a4efa8	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076543 application number: ANDA076543 ndc (product): 51672-1310
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	75862805-2cfc-fb45-e053-2991aa0a1403	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076543 application number: ANDA076543 ndc (product): 68071-4556
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Asclemed USA, Inc	86994546-929c-4303-89e4-31ba271673cf	2024-10-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076543 application number: ANDA076543

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5232	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
50090-5232	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
50090-5232	Betamethasone Dipropionate	Betamethasone Dipropionate	A-S Medication Solutions	ANDA	Current
51672-1310	Betamethasone Dipropionate	Betamethasone Dipropionate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1310	Betamethasone Dipropionate	Betamethasone Dipropionate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
51672-1310	Betamethasone Dipropionate	Betamethasone Dipropionate	Taro Pharmaceuticals U.S.A., Inc.	ANDA	Current
68071-4556	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4556	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4556	Betamethasone Dipropionate	Betamethasone Dipropionate	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7670	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7670	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7670	Betamethasone Dipropionate	Betamethasone Dipropionate	Preferred Pharmaceuticals, Inc.	ANDA	Current