Betamethasone Dipropionate

Product NDC: 0168-0265
11-digit product format: 001680265
Labeler code: 0168
Product ID: 0168-0265_98a5f88e-6ba5-4064-b851-17b63a13e883
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone dipropionate
Dosage form: CREAM, AUGMENTED
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Application: ANDA076215
Marketing category: ANDA
Marketing start: 2003-12-09
Marketing end: 0000-00-00
Substance: BETAMETHASONE DIPROPIONATE
Active strength: 1 mg/g
Pharmacologic classes: Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0168-0265		D	Discontinued by firm	2026-08-17
excluded package	package	0168-0265	0168-0265-15	D	Discontinued by firm	2026-08-17
excluded package	package	0168-0265	0168-0265-50	D	Discontinued by firm	2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0265-15	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0168-0265-50	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0265-15	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0168-0265-50	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0265-15	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0168-0265-50	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0265-15	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0168-0265-50	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0265-15	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0168-0265-50	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0265-15	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0168-0265-50	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0168-0265-50	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0168-0265-15	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`

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
A076215-001	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
A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076215-001	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	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076215-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	CREAM, AUGMENTED / TOPICAL	AB	2003-12-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076215-001	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	A076215-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076215-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076215-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076215-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076215-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076215-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076215-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076215-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076215-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076215-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076215-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076215-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076215-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076215-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076215-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076215-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076215-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076215-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076215-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076215-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076215-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076215-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076215-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076215-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076215-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076215-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076215-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076215-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076215-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076215-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076215-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076215-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076215-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076215-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076215-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076215-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076215-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076215-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076215-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076215-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0168-0265-15	2020-12-07	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-50	2020-12-07	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-15	2020-09-27	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-50	2020-09-27	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-15	2020-09-25	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-50	2020-09-25	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-15	2020-07-22	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983
0168-0265-50	2020-07-22	These highlights do not include all the information needed to use. BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Cream, 0.05% (Augmented). BETAMETHASONE DIPROPIONATE cream, 0.05 % (augmented) for topical use Initial U.S. Approval: 1983

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0265-15	GM - Gram	0168-0265	dd1b5e6a-735e-4e5d-ae16-3667b06b3dce	1	2012-07-24
0168-0265-50	GM - Gram	0168-0265	4db48579-957b-42d4-a1d0-9027ddc15684	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
CETEARETH-30	INACTIVE INGREDIENT	1R9DCZ5FOX	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	7
BETAMETHASONE DIPROPIONATE	ACTIVE INGREDIENT	826Y60901U	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
CETEARETH-30	INACTIVE INGREDIENT	1R9DCZ5FOX	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	BETAMETHASONE DIPROPIONATE CREAM, AUGMENTED [PROFICIENT RX LP]	1

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	Marketing end	Sample	Exclude flag	Status
0168-0265-15	00168026515	15 g in 1 TUBE (0168-0265-15)	15 g	2003-12-09	0000-00-00	No	No	Current
0168-0265-50	00168026550	50 g in 1 TUBE (0168-0265-50)	50 g	2003-12-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Betamethasone Dipropionate	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Betamethasone Dipropionate	E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.	2020-09-11	HUMAN PRESCRIPTION DRUG LABEL	15