Fluconazole

Product NDC: 0172-5412
11-digit product format: 001725412
Labeler code: 0172
Product ID: 0172-5412_27a18adf-4a27-479c-bd3c-a58938662ee1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA076077
Marketing category: ANDA
Marketing start: 2004-07-29
Marketing end: 2022-06-30
Substance: FLUCONAZOLE
Active strength: 150 mg/1
Pharmacologic classes: Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
74f0b828-cb79-42cb-bb6c-81c9f5bd2648	Product name	2	20250623
fe6bb120-ebc6-6290-9eab-e842fdb6c841	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0172-5412-11	EA - Each	0172-5412	f47f2c1c-cbf0-4b0d-8377-3b6985d9ecd2	1	2012-07-24
0172-5412-79	EA - Each	0172-5412	1a8f39df-032a-426a-96b5-a51727e774d1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [DIRECT RX]	2
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [DIRECT RX]	2
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUCONAZOLE TABLET [DIRECT RX]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [DIRECT RX]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [DIRECT RX]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [DIRECT RX]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUCONAZOLE TABLET [DIRECT RX]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [DIRECT RX]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUCONAZOLE TABLET [DIRECT RX]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUCONAZOLE TABLET [DIRECT RX]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUCONAZOLE TABLET [DIRECT RX]	2
Fluconazole	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Fluconazole	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
FD&C Red NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Lactose Monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Silicon Dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Starch, Corn	INACTIVE INGREDIENT	O8232NY3SJ	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	FLUCONAZOLE TABLET [APOTHECARY SHOP WHOLESALE INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUCONAZOLE TABLET [MEDVANTX, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8VZV102JFY	FLUCONAZOLE	86386-73-4	FLUCONAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197699	fluconazole 150 MG Oral Tablet	PSN	f70c14ff-4bdc-4c1f-a118-ff3e85a04302	2
197699	fluconazole 150 MG Oral Tablet	SCD	f70c14ff-4bdc-4c1f-a118-ff3e85a04302	2
197699	fluconazole 150 MG Oral Tablet	PSN	5314ab7a-e750-4e6b-8ef2-e37f831e088b	1
197699	fluconazole 150 MG Oral Tablet	PSN	8267f4f7-a557-400e-a1d8-07825c39f9ef	1
197699	fluconazole 150 MG Oral Tablet	PSN	892aa268-0790-4e2c-8faa-d8cbeb200abd	1
197699	fluconazole 150 MG Oral Tablet	SCD	5314ab7a-e750-4e6b-8ef2-e37f831e088b	1
197699	fluconazole 150 MG Oral Tablet	SCD	8267f4f7-a557-400e-a1d8-07825c39f9ef	1
197699	fluconazole 150 MG Oral Tablet	SCD	892aa268-0790-4e2c-8faa-d8cbeb200abd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-5412-11	00172541211	12 BLISTER PACK in 1 BOX (0172-5412-11) > 1 TABLET in 1 BLISTER PACK (0172-5412-79)	12 blister pack	2004-07-29	2022-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUCONAZOLE	DIRECT RX	2015-06-25	HUMAN PRESCRIPTION DRUG LABEL	2
FLUCONAZOLE TABLETS	MedVantx, Inc. \| IVAX Pharmaceuticals Inc \| Blenheim Pharmacal, Inc.	2012-07-31	HUMAN PRESCRIPTION DRUG LABEL	1
FLUCONAZOLE TABLETS	MedVantx, Inc. \| IVAX Pharmaceuticals Inc \| Blenheim Pharmacal, Inc.	2011-12-21	HUMAN PRESCRIPTION DRUG LABEL	1
FLUCONAZOLE TABLETS	Apothecary Shop Wholesale Inc.	2011-06-21	HUMAN PRESCRIPTION DRUG LABEL	1

Fluconazole

DailyMed Product Concepts#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#