BETAMETHASONE DIPROPIONATE

Product NDC: 35573-107
11-digit product format: 355730107
Labeler code: 35573
Product ID: 35573-107_c8bda9a8-4dec-4084-84e5-4b4623390bd8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BETAMETHASONE DIPROPIONATE
Dosage form: OINTMENT, AUGMENTED
Route: TOPICAL
Labeler: Burel Pharmaceuticals, LLC
Application: ANDA218289
Marketing category: ANDA
Marketing start: 2025-01-15
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
A218289-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB		2024-04-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218289-001	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.

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	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218289-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	OINTMENT, AUGMENTED / TOPICAL	AB	2024-04-10	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A218289-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A218289-001	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218289-001	AB	1	`a50c72e98297…`

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
848180	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
c8bda9a8-4dec-4084-84e5-4b4623390bd8	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
35573-107-15	BETAMETHASONE DIPROPIONATE	1 in 1 CARTON	OINTMENT, AUGMENTED	1	1
35573-107-15	BETAMETHASONE DIPROPIONATE	15 g in 1 TUBE	OINTMENT, AUGMENTED	15	1
35573-107-49	BETAMETHASONE DIPROPIONATE	1 in 1 CARTON	OINTMENT, AUGMENTED	1	1
35573-107-49	BETAMETHASONE DIPROPIONATE	50 g in 1 TUBE	OINTMENT, AUGMENTED	50	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35573-107-15	GM - Gram	35573-107	1aae3170-9df8-4360-8b8a-6d86fa583554	1	2025-03-04
35573-107-49	GM - Gram	35573-107	35ba7533-b201-452d-b12f-83d555b1b212	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
35573-107	BETAMETHASONE DIPROPIONATE OINTMENT, AUGMENTED [BUREL PHARMACEUTICALS, LLC]	1	Current NDC, 4 package rows	20250115_c8bda9a8-4dec-4084-84e5-4b4623390bd8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Burel Pharmaceuticals, LLC	c8bda9a8-4dec-4084-84e5-4b4623390bd8	2024-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218289 application number: ANDA218289 ndc (product): 35573-107
BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	Aurobindo Pharma Limited	e0e0baea-1744-4708-bda7-4ab7783a3fb4	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218289 application number: ANDA218289

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
848180	betamethasone dipropionate 0.05 % Augmented Topical Ointment	PSN	c8bda9a8-4dec-4084-84e5-4b4623390bd8	1
848180	Augmented betamethasone 0.0005 MG/MG Topical Ointment	SCD	c8bda9a8-4dec-4084-84e5-4b4623390bd8	1
848180	augmented betamethasone 0.05 % Topical Ointment	SY	c8bda9a8-4dec-4084-84e5-4b4623390bd8	1
848180	betamethasone 0.05 % Augmented Topical Ointment	SY	c8bda9a8-4dec-4084-84e5-4b4623390bd8	1
848180	betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical Ointment	SY	c8bda9a8-4dec-4084-84e5-4b4623390bd8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
35573-107-15	35573010715	1 TUBE in 1 CARTON (35573-107-15) / 15 g in 1 TUBE	1 tube	2025-01-15	No	No	Current
35573-107-49	35573010749	1 TUBE in 1 CARTON (35573-107-49) / 50 g in 1 TUBE	1 tube	2025-01-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETAMETHASONE DIPROPIONATE	Burel Pharmaceuticals, LLC \| Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2024-12-04	Human Prescription Drug Label	1