Betamethasone Dipropionate

Product NDC: 21922-104
11-digit product format: 219220104
Labeler code: 21922
Product ID: 21922-104_cb91d996-4591-4ff4-8468-186aa4f7d837
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BETAMETHASONE DIPROPIONATE
Dosage form: LOTION, AUGMENTED
Route: TOPICAL
Labeler: Encube Ethicals, Inc.
Application: ANDA206389
Marketing category: ANDA
Marketing start: 2025-11-25
Substance: BETAMETHASONE DIPROPIONATE
Active strength: .5 mg/mL
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
A206389-001	BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB		2018-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206389-001	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	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL		2018-02-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206389-001	BETAMETHASONE DIPROPIONATE	EQ 0.05% BASE	LOTION, AUGMENTED / TOPICAL	AB	2018-02-13	`e64feba35796…`

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	A206389-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206389-001	AB	1	`011fe1cb6892…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206389-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206389-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206389-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206389-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206389-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206389-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206389-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206389-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206389-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206389-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206389-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206389-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206389-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A206389-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206389-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206389-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206389-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206389-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206389-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206389-001	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/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
7e946599-2fb4-4426-bb59-fbb71d89dac8	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
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
21922-104-01	Betamethasone Dipropionate	60 mL in 1 BOTTLE, PLASTIC	LOTION, AUGMENTED	60	2
21922-104-01	Betamethasone Dipropionate	1 in 1 CARTON	LOTION, AUGMENTED	1	2
21922-104-21	Betamethasone Dipropionate	1 in 1 CARTON	LOTION, AUGMENTED	1	2
21922-104-21	Betamethasone Dipropionate	30 mL in 1 BOTTLE, PLASTIC	LOTION, AUGMENTED	30	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-104-01	ML - Milliliter	21922-104	efb265d6-2174-413c-a102-0bb3e8625ff5	1	2026-03-17
21922-104-21	ML - Milliliter	21922-104	d05f349a-068f-46f9-a8e1-d98e10ec4abc	1	2026-03-17

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	Encube Ethicals, Inc.	7e946599-2fb4-4426-bb59-fbb71d89dac8	2025-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206389 application number: ANDA206389 ndc (product): 21922-104

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	7e946599-2fb4-4426-bb59-fbb71d89dac8	2
848178	Augmented betamethasone 0.5 MG/ML Topical Lotion	SCD	7e946599-2fb4-4426-bb59-fbb71d89dac8	2
848178	augmented betamethasone 0.05 % Topical Lotion	SY	7e946599-2fb4-4426-bb59-fbb71d89dac8	2
848178	betamethasone 0.05 % (betamethasone diproprionate 0.64 MG/ML) Augmented Topical Lotion	SY	7e946599-2fb4-4426-bb59-fbb71d89dac8	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
21922-104-01	21922010401	1 BOTTLE, PLASTIC in 1 CARTON (21922-104-01) / 60 mL in 1 BOTTLE, PLASTIC	2025-11-25	No	No	Current
21922-104-21	21922010421	1 BOTTLE, PLASTIC in 1 CARTON (21922-104-21) / 30 mL in 1 BOTTLE, PLASTIC	2025-11-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Betamethasone Dipropionate	Encube Ethicals, Inc. \| Encube Ethicals Private Limited	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	2