Ketoconazole

Product NDC: 0093-0900
11-digit product format: 000930900
Labeler code: 0093
Product ID: 0093-0900_01e34bdb-92ed-4caa-9781-5f0c6245c224
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ketoconazole
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075273
Marketing category: ANDA
Marketing start: 1999-06-15
Marketing end: 0000-00-00
Substance: KETOCONAZOLE
Active strength: 200 mg/1
Pharmacologic classes: Azole Antifungal [EPC],Azoles [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A5 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5	Product name	2	20250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2	Product name	2	20211209
8bc3781f-20ed-678b-44a7-a981e693c65f	Product name	2	20211209
ff3a8c91-648c-300b-467e-10703f514265	Product name	2	20180809
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3	Product name	1	20140508

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-0900-01	EA - Each	0093-0900	ca9edea7-138e-4609-93ee-ad4ad7947ffa	1	2012-07-24
0093-0900-05	EA - Each	0093-0900	70a4f35c-5216-4f6e-b357-c8cb4352be5f	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [CARILION MATERIALS MANAGEMENT]	2
KETOCONAZOLE	ACTIVE INGREDIENT	R9400W927I	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
KETOCONAZOLE	ACTIVE MOIETY	R9400W927I	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	KETOCONAZOLE TABLET [STAT RX USA LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	KETOCONAZOLE TABLET [STAT RX USA LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R9400W927I	KETOCONAZOLE	65277-42-1	KETOCONAZOLE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197853	ketoconazole 200 MG Oral Tablet	PSN	be550113-f75c-4aec-86ed-c4a0c1a6f704	5
197853	ketoconazole 200 MG Oral Tablet	SCD	be550113-f75c-4aec-86ed-c4a0c1a6f704	5
197853	ketoconazole 200 MG Oral Tablet	PSN	d9dd50aa-e8d9-4839-ae92-26135415357e	1
197853	ketoconazole 200 MG Oral Tablet	SCD	d9dd50aa-e8d9-4839-ae92-26135415357e	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
KETOCONAZOLE TABLETS USP, 200 mg Rx only	Carilion Materials Management	2017-12-26	HUMAN PRESCRIPTION DRUG LABEL	5
KETOCONAZOLE TABLETS USP, 200 mg 0900	STAT RX USA LLC	2011-09-08	HUMAN PRESCRIPTION DRUG LABEL	1