CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE

Product NDC: 72189-182
11-digit product format: 721890182
Labeler code: 72189
Product ID: 72189-182_2be953af-ba6f-e430-e063-6294a90a9a1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
Dosage form: CREAM
Route: TOPICAL
Labeler: Direct Rx
Application: ANDA202894
Marketing category: ANDA
Marketing start: 2021-02-23
Substance: BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength: .5; 10 mg/g; mg/g
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
BETAMETHASONE DIPROPIONATE	.5 mg/g
CLOTRIMAZOLE	10 mg/g

Field, Values table
Field	Values
Unii	826Y60901U, G07GZ97H65
Rxcui	308714

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b64d2752-34ef-378a-1f4f-8bff32b0d1ae	Product name	4	20250626
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
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9	Product name	2	20250121
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
f5395dd2-4395-d8c6-3477-8c2d4a2f951c	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72189-182-15	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	15 g in 1 TUBE	CREAM	15		2

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-182	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [DIRECT RX]	2	Current NDC, Legacy NDC, 1 package rows	20250119_bbf26437-c9b4-d8e6-e053-2a95a90a0062.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
826Y60901U	BETAMETHASONE DIPROPIONATE	5593-20-4	BETAMETHASONE DIPROPIONATE
G07GZ97H65	CLOTRIMAZOLE	23593-75-1	CLOTRIMAZOLE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308714	clotrimazole 1 % / betamethasone 0.05 % Topical Cream	PSN	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical Cream	SCD	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	betamethasone 0.05 % / clotrimazole 1 % Topical Cream	SY	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2
308714	betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical Cream	SY	bbf26437-c9b4-d8e6-e053-2a95a90a0062	2

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-182-15	72189018215	15 g in 1 TUBE (72189-182-15)	15 g	2021-02-23	0000-00-00	No	No	Current