Betamethasone Dipropionate

Product NDC: 21695-521
11-digit product format: 216950521
Labeler code: 21695
Product ID: 21695-521_7ca6552c-bd9f-4630-b202-38dea8b7d994
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Betamethasone Dipropionate
Dosage form: CREAM
Route: TOPICAL
Labeler: Rebel Distributors Corp.
Application: ANDA019137
Marketing category: ANDA
Marketing start: 1984-02-26
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: E
Listing certified through: 2017-12-31
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	21695-521		I	Inactivated by FDA	2026-08-17
excluded package	package	21695-521	21695-521-15	I	Inactivated by FDA	2026-08-17
excluded package	package	21695-521	21695-521-45	I	Inactivated by FDA	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 2 · 66 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-521-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	21695-521-45	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-521-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	21695-521-45	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-521-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	21695-521-45	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-521-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	21695-521-45	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-521-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	21695-521-45	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-521-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	21695-521-45	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-521-15	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-521-45	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-521-15	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-521-45	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-521-15	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-521-45	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-521-15	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-521-45	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-521-15	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-521-45	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-521-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-521-45	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-521-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-521-45	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-521-15	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-521-45	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-521-15	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-521-45	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-521-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-521-45	`fb8cb913e6d1…`	`eb8c232b6be0…`
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	21695-521-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-521-45	`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	21695-521-15	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-521-45	`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	21695-521-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-521-45	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-521-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-521-45	`e2bbac7714bc…`	`27bdfed8d636…`

Source provenance: Browse the complete Orange Book source catalog.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-521-15	2019-09-24	C162847	48780-1	934fe258-4af4-48b1-e053-8cdaa90a720a	BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%
21695-521-45	2019-09-24	C162847	48780-1	934fe258-4af4-48b1-e053-8cdaa90a720a	BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-521-15	Betamethasone Dipropionate	15 g in 1 TUBE	CREAM	15		1
21695-521-45	Betamethasone Dipropionate	45 g in 1 TUBE	CREAM	45		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-521-15	GM - Gram	21695-521	9c04dbc7-1c8c-43dc-84b7-13b40b33d0c0	1	2012-07-24
21695-521-45	GM - Gram	21695-521	591cdd94-57cb-4f68-b6d9-ab9a6f76582a	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 [REBEL DISTRIBUTORS CORP.]	1
betamethasone	ACTIVE MOIETY	9842X06Q6M	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
ceteth-20	INACTIVE INGREDIENT	I835H2IHHX	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
chlorocresol	INACTIVE INGREDIENT	36W53O7109	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
phosphoric acid	INACTIVE INGREDIENT	E4GA8884NN	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
sodium phosphate, monobasic, monohydrate	INACTIVE INGREDIENT	593YOG76RN	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-521	BETAMETHASONE DIPROPIONATE CREAM [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 2 package rows	20110511_7ca6552c-bd9f-4630-b202-38dea8b7d994.zip

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
238920	betamethasone 0.05 % Topical Cream	PSN	7ca6552c-bd9f-4630-b202-38dea8b7d994	1
238920	betamethasone 0.5 MG/ML Topical Cream	SCD	7ca6552c-bd9f-4630-b202-38dea8b7d994	1
238920	betamethasone 0.05 % Topical Cream	SY	7ca6552c-bd9f-4630-b202-38dea8b7d994	1
238920	betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Topical Cream	SY	7ca6552c-bd9f-4630-b202-38dea8b7d994	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
21695-521-15	21695052115	15 g in 1 TUBE	15 g	Historical
21695-521-45	21695052145	45 g in 1 TUBE	45 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETAMETHASONE DIPROPIONATE CREAM USP, 0.05% BETAMETHASONE DIPROPIONATE OINTMENT USP, 0.05% BETAMETHASONE DIPROPIONATE LOTION USP, 0.05%	Rebel Distributors Corp.	2010-09-14	HUMAN PRESCRIPTION DRUG LABEL	1