Betamethasone Dipropionate

Product NDC: 0168-0267
11-digit product format: 001680267
Labeler code: 0168
Product ID: 0168-0267_5d745268-8539-4108-a0eb-444a4b1424b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone Dipropionate
Dosage form: LOTION, AUGMENTED
Route: TOPICAL
Labeler: E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application: ANDA077111
Marketing category: ANDA
Marketing start: 2007-05-21
Substance: BETAMETHASONE DIPROPIONATE
Active strength: .5 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 9 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0168-0267-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0168-0267-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0168-0267-30	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0168-0267-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0168-0267-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0168-0267-60	`8dfbde2a14a4…`	`c9ff85d89658…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077111-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB		2007-05-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077111-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077111-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2007-05-21	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077111-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077111-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077111-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077111-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077111-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077111-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077111-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077111-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077111-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077111-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077111-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077111-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077111-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077111-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077111-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077111-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077111-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077111-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077111-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077111-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077111-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077111-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077111-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077111-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077111-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077111-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077111-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077111-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077111-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077111-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077111-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077111-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077111-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077111-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077111-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077111-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077111-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077111-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077111-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077111-001	AB	1	`cb3db0bc1861…`

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/mL

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
848178	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
4f411e41-00dc-47cf-8517-3ff5876e1bf5	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0168-0267-30	2022-07-01	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-60	2022-07-01	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-30	2021-07-23	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-60	2021-07-23	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-30	2020-09-18	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-60	2020-09-18	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-30	2020-07-22	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983
0168-0267-60	2020-07-22	These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05% safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE Lotion (Augmented), 0.05%. BETAMETHASONE DIPROPIONATE lotion (Augmented), 0.05% for topical use Initial U.S. Approval: 1983

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0168-0267-30	Betamethasone Dipropionate	30 mL in 1 BOTTLE	LOTION, AUGMENTED	30		13
0168-0267-60	Betamethasone Dipropionate	60 mL in 1 BOTTLE	LOTION, AUGMENTED	60		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0267-30	ML - Milliliter	0168-0267	a8ec8087-e57e-4d0f-b520-5aa974cb087b	1	2012-07-24
0168-0267-60	ML - Milliliter	0168-0267	2977b032-3b0c-442e-a1a2-bcaab36d2c51	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 LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
BETAMETHASONE	ACTIVE MOIETY	9842X06Q6M	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
phosphoric acid	INACTIVE INGREDIENT	E4GA8884NN	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
water	INACTIVE INGREDIENT	059QF0KO0R	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	5
betamethasone dipropionate	ACTIVE INGREDIENT	826Y60901U	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
betamethasone dipropionate	ACTIVE MOIETY	826Y60901U	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
hydroxypropyl cellulose	INACTIVE INGREDIENT	RFW2ET671P	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
phosphoric acid	INACTIVE INGREDIENT	E4GA8884NN	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2
water	INACTIVE INGREDIENT	059QF0KO0R	BETAMETHASONE DIPROPIONATE AUGMENTED (BETAMETHASONE DIPROPIONATE) LOTION [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0267	BETAMETHASONE DIPROPIONATE LOTION, AUGMENTED [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	12	Current NDC, Legacy NDC, 2 package rows	20220702_4f411e41-00dc-47cf-8517-3ff5876e1bf5.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Betamethasone Dipropionate	BETAMETHASONE DIPROPIONATE	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	4f411e41-00dc-47cf-8517-3ff5876e1bf5	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077111 application number: ANDA077111 ndc (product): 0168-0267

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
848178	betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical Lotion	PSN	4f411e41-00dc-47cf-8517-3ff5876e1bf5	13
848178	Augmented betamethasone 0.5 MG/ML Topical Lotion	SCD	4f411e41-00dc-47cf-8517-3ff5876e1bf5	13
848178	augmented betamethasone 0.05 % Topical Lotion	SY	4f411e41-00dc-47cf-8517-3ff5876e1bf5	13
848178	betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical Lotion	SY	4f411e41-00dc-47cf-8517-3ff5876e1bf5	13
848178	betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical Lotion	PSN	90d6c26b-3623-477e-afca-7028587bdf80	2
848178	Augmented betamethasone 0.5 MG/ML Topical Lotion	SCD	90d6c26b-3623-477e-afca-7028587bdf80	2
848178	augmented betamethasone 0.05 % Topical Lotion	SY	90d6c26b-3623-477e-afca-7028587bdf80	2
848178	betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical Lotion	SY	90d6c26b-3623-477e-afca-7028587bdf80	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0168-0267-30	00168026730	30 mL in 1 BOTTLE (0168-0267-30)	30 ml	2007-05-21	0000-00-00	No	No	Current
0168-0267-60	00168026760	60 mL in 1 BOTTLE (0168-0267-60)	60 ml	2007-05-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Betamethasone Dipropionate	E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	13
Betamethasone Dipropionate Augmented	Physicians Total Care, Inc.	2009-07-15	HUMAN PRESCRIPTION DRUG LABEL	2