Betamethasone Dipropionate

Product NDC: 63629-8613
11-digit product format: 636298613
Labeler code: 63629
Product ID: 63629-8613_bb35a5f9-bda6-49bd-88a4-4681c540cda3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone Dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Bryant Ranch Prepack
Application: ANDA076592
Marketing category: ANDA
Marketing start: 2006-09-28
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
A076592-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB		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
A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076592-001	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	A076592-001	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	A076592-001	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	A076592-001	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	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076592-001	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	A076592-001	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	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076592-001	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	A076592-001	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	A076592-001	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	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076592-001	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	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076592-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076592-001	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	A076592-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076592-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076592-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076592-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076592-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076592-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076592-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076592-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076592-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076592-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076592-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076592-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076592-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076592-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076592-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076592-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076592-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076592-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076592-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076592-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076592-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076592-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076592-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076592-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076592-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076592-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076592-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076592-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076592-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076592-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076592-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076592-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076592-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076592-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076592-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076592-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076592-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076592-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076592-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076592-001	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
0481ac0d-9220-472b-b3f2-af6e0bb6962d	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63629-8613-1	Betamethasone Dipropionate	1 in 1 CARTON	CREAM	1		105
63629-8613-1	Betamethasone Dipropionate	15 g in 1 TUBE	CREAM	15		105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-8613-1	GM - Gram	63629-8613	51e1ac94-cabd-41f9-adf1-933692542437	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8613	BETAMETHASONE DIPROPIONATE CREAM [BRYANT RANCH PREPACK]	105	Current NDC, Legacy NDC, 2 package rows	20240822_0481ac0d-9220-472b-b3f2-af6e0bb6962d.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 · 7 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.	5683885d-461c-4e7e-bbe8-dc231d706192	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	f2c557ea-275b-4ab4-90f4-4003e022214d	2025-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	0481ac0d-9220-472b-b3f2-af6e0bb6962d	2024-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592 ndc (product): 63629-8613
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	NuCare Pharmaceuticals,Inc.	84b37e6a-779e-5d43-e053-2a91aa0a16b7	2024-06-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Bryant Ranch Prepack	79256f36-adff-4628-abc5-cb25bdfdc19d	2024-01-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Padagis Israel Pharmaceuticals Ltd	7bd2646c-f34a-4824-8f66-c41e77db19d2	2023-03-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	Proficient Rx LP	f1be7c91-5408-4d31-8673-b691089aadce	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076592 application number: ANDA076592

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	0481ac0d-9220-472b-b3f2-af6e0bb6962d	105
848176	Augmented betamethasone 0.5 MG/ML Topical Cream	SCD	0481ac0d-9220-472b-b3f2-af6e0bb6962d	105
848176	augmented betamethasone 0.05 % Topical Cream	SY	0481ac0d-9220-472b-b3f2-af6e0bb6962d	105
848176	betamethasone 0.05 % (betamethasone dipropionate 0.064 % ) Augmented Topical Cream	SY	0481ac0d-9220-472b-b3f2-af6e0bb6962d	105

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8613-1	63629861301	1 TUBE in 1 CARTON (63629-8613-1) / 15 g in 1 TUBE	1 tube	2021-07-09	0000-00-00	No	No	Current