Ketodan

Product NDC: 43538-531
11-digit product format: 435380531
Labeler code: 43538
Product ID: 43538-531_0ea6f081-8714-4c58-a811-1a1c091a4dcf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ketoconazole
Dosage form: KIT
Labeler: Medimetriks Pharmaceuticals, Inc.
Application: ANDA091550
Marketing category: ANDA
Marketing start: 2012-06-15
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43538-531-10	2021-12-08	C162847	48780-1	c7ccaba7-197d-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use KETODAN ® FOAM safely and effectively. See full prescribing information for KETODAN ® FOAM. KETODAN ® (KETOCONAZOLE) Foam, 2% For topical use Initial U.S. Approval: 1981
43538-531-10	2021-07-23	C162847	48780-1	c7ccaba7-197d-fd44-e053-dadaa90aa01b	These highlights do not include all the information needed to use KETODAN ® FOAM safely and effectively. See full prescribing information for KETODAN ® FOAM. KETODAN ® (KETOCONAZOLE) Foam, 2% For topical use Initial U.S. Approval: 1981

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43538-531-10	GM - Gram	43538-531	d39ac880-6e37-4fed-96cd-76fbe21335d6	1	2013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43538-531-10	43538053110	1 KIT in 1 CARTON (43538-531-10) * 454 g in 1 BOTTLE, PUMP * 100 g in 1 CAN	1 kit	2012-06-15	0000-00-00	No	No	Current