Betamethasone dipropionate

Product NDC: 67296-2275
11-digit product format: 672962275
Labeler code: 67296
Product ID: 67296-2275_5718b38e-7e06-b138-e063-6394a90a12f4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Redpharm Drug
Application: ANDA208885
Marketing category: ANDA
Marketing start: 2019-10-10
Substance: BETAMETHASONE DIPROPIONATE
Active strength: .5 mg/g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208885-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB		2019-01-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208885-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208885-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM / TOPICAL	AB	2019-01-11	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208885-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208885-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208885-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208885-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208885-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208885-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208885-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208885-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208885-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208885-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208885-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208885-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208885-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208885-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208885-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208885-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208885-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208885-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208885-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208885-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208885-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208885-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208885-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208885-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208885-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208885-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208885-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208885-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208885-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208885-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208885-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208885-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208885-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208885-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208885-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208885-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208885-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208885-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208885-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208885-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Betamethasone dipropionate
Listing expiration: 2027-12-31

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
238920	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
5718b3bd-77b3-8034-e063-6294a90af5e0	Available on FDA.report

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Redpharm Drug	5718b3bd-77b3-8034-e063-6294a90af5e0	2026-07-21	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885 ndc (product): 67296-2275
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	07a35811-7298-4f25-b280-e2f9aeab9830	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Northstar Rx LLC.	395d40c0-22d9-48d1-8d8e-eeaddf33c53e	2024-12-05	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Lifesciences Limited	bc9ca1f4-8f40-44e1-bb2d-42ecba35d406	2024-11-25		Exact identifier application applno (ANDA): 208885 application number: ANDA208885
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	A-S Medication Solutions	1c15cbe5-51d6-4a1a-bb42-811f1d84ae66	2023-10-31	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885
Betamethasone dipropionate	BETAMETHASONE DIPROPIONATE	Zydus Pharmaceuticals USA Inc.	18d80661-72ad-4a83-917f-a80ce37a5568	2022-10-05	Adverse reactions	Exact identifier application applno (ANDA): 208885 application number: ANDA208885

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67296-2275-1	67296227501	1 TUBE in 1 CARTON (67296-2275-1) / 15 g in 1 TUBE	1 tube	2019-10-10	No	No	Current