Betamethasone Dipropionate

Product NDC: 76420-858
11-digit product format: 764200858
Labeler code: 76420
Product ID: 76420-858_2432f862-6d58-666d-e063-6294a90acf74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone Dipropionate
Dosage form: CREAM, AUGMENTED
Route: TOPICAL
Labeler: Asclemed USA, Inc
Application: ANDA076543
Marketing category: ANDA
Marketing start: 2003-12-09
Substance: BETAMETHASONE DIPROPIONATE
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

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Betamethasone Dipropionate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BETAMETHASONE DIPROPIONATE	.5 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
826Y60901U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
848176	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
86994546-929c-4303-89e4-31ba271673cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dde7b902-54a1-627e-12f1-9e6d244ab88c	Product name	4	20250317
69b49899-11cf-4f7e-bd0a-7dc93b27311b	Product name	3	20250130
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
0a2fcc35-464b-9ec2-a622-753662cdd48c	Product name	3	20240216
6f762601-17ef-4321-8f47-77783d3c4d8b	Product name	3	20231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70	Product name	5	20220921
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405d	Product name	1	20160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6	Product name	2	20151106
4f07db9b-3707-3e2c-05b5-d7852ba808c4	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-858-15	Betamethasone Dipropionate	15 g in 1 TUBE	CREAM, AUGMENTED	15	1
76420-858-15	Betamethasone Dipropionate	1 in 1 CARTON	CREAM, AUGMENTED	1	1
76420-858-30	Betamethasone Dipropionate	1 in 1 CARTON	CREAM, AUGMENTED	1	1
76420-858-30	Betamethasone Dipropionate	30 g in 1 TUBE	CREAM, AUGMENTED	30	1
76420-858-50	Betamethasone Dipropionate	1 in 1 CARTON	CREAM, AUGMENTED	1	1
76420-858-50	Betamethasone Dipropionate	50 g in 1 TUBE	CREAM, AUGMENTED	50	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-858	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [ASCLEMED USA, INC]	1	Current NDC, 6 package rows	20241016_86994546-929c-4303-89e4-31ba271673cf.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
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
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
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
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
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 (product): 76420-858

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848176	betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical Cream	PSN	86994546-929c-4303-89e4-31ba271673cf	1
848176	Augmented betamethasone 0.5 MG/ML Topical Cream	SCD	86994546-929c-4303-89e4-31ba271673cf	1
848176	augmented betamethasone 0.05 % Topical Cream	SY	86994546-929c-4303-89e4-31ba271673cf	1
848176	betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical Cream	SY	86994546-929c-4303-89e4-31ba271673cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
76420-858-15	76420085815	1 TUBE in 1 CARTON (76420-858-15) / 15 g in 1 TUBE	1 tube	2024-10-11	No	No	Current
76420-858-30	76420085830	1 TUBE in 1 CARTON (76420-858-30) / 30 g in 1 TUBE	1 tube	2024-10-11	No	No	Current
76420-858-50	76420085850	1 TUBE in 1 CARTON (76420-858-50) / 50 g in 1 TUBE	1 tube	2024-10-11	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Betamethasone Dipropionate	Asclemed USA, Inc \| ASCLEMED USA INC. DBA ENOVACHEM	2024-10-11	HUMAN PRESCRIPTION DRUG LABEL	1