Fluconazole

Product NDC: 68462-104
11-digit product format: 684620104
Labeler code: 68462
Product ID: 68462-104_639b832d-b798-4efb-8db0-e64b8ba81574
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA077253
Marketing category: ANDA
Marketing start: 2006-01-25
Substance: FLUCONAZOLE
Active strength: 200 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: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Fluconazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	200 mg/1

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	8VZV102JFY
Rxcui	197698, 197699, 197700, 197701

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68462-104-10	Fluconazole	1000 in 1 BOTTLE	TABLET	1000		23
68462-104-30	Fluconazole	30 in 1 BOTTLE	TABLET	30		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-104-30	EA - Each	68462-104	bd2baaeb-93d9-4b51-afe7-1b3f6997321b	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	10
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]	5
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [DISPENSING SOLUTIONS, INC.]	2
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
FLUCONAZOLE	ACTIVE INGREDIENT	8VZV102JFY	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
FLUCONAZOLE	ACTIVE MOIETY	8VZV102JFY	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	FLUCONAZOLE TABLET [BLENHEIM PHARMACAL, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	DIRECT RX (FLUCONAZOLE) TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-104	FLUCONAZOLE TABLET [GLENMARK PHARMACEUTICALS INC., USA]	22	Current NDC, Legacy NDC, 2 package rows	20240405_3da5f41d-5200-45ac-b89d-00881237ec85.zip

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
197700	fluconazole 200 MG Oral Tablet	PSN	dd975843-c3e4-44f4-bb0d-33b294c1f6fb	31
197700	fluconazole 200 MG Oral Tablet	SCD	dd975843-c3e4-44f4-bb0d-33b294c1f6fb	31
197698	fluconazole 100 MG Oral Tablet	PSN	3da5f41d-5200-45ac-b89d-00881237ec85	23
197699	fluconazole 150 MG Oral Tablet	PSN	3da5f41d-5200-45ac-b89d-00881237ec85	23
197700	fluconazole 200 MG Oral Tablet	PSN	3da5f41d-5200-45ac-b89d-00881237ec85	23
197701	fluconazole 50 MG Oral Tablet	PSN	3da5f41d-5200-45ac-b89d-00881237ec85	23
197698	fluconazole 100 MG Oral Tablet	SCD	3da5f41d-5200-45ac-b89d-00881237ec85	23
197699	fluconazole 150 MG Oral Tablet	SCD	3da5f41d-5200-45ac-b89d-00881237ec85	23
197700	fluconazole 200 MG Oral Tablet	SCD	3da5f41d-5200-45ac-b89d-00881237ec85	23
197701	fluconazole 50 MG Oral Tablet	SCD	3da5f41d-5200-45ac-b89d-00881237ec85	23
197700	fluconazole 200 MG Oral Tablet	PSN	69f199fa-bb92-4837-8b12-427a1c71f622	6
197700	fluconazole 200 MG Oral Tablet	SCD	69f199fa-bb92-4837-8b12-427a1c71f622	6
197700	fluconazole 200 MG Oral Tablet	PSN	fbb1bda3-f733-4404-9c9d-46c418700c03	4
197700	fluconazole 200 MG Oral Tablet	SCD	fbb1bda3-f733-4404-9c9d-46c418700c03	4
197700	fluconazole 200 MG Oral Tablet	PSN	aa7572ca-0ea0-4259-bc79-acb88c9f492d	2
197700	fluconazole 200 MG Oral Tablet	SCD	aa7572ca-0ea0-4259-bc79-acb88c9f492d	2
197698	fluconazole 100 MG Oral Tablet	PSN	8e80f9d8-2577-4fd9-a455-e6c6dc244c3a	1
197699	fluconazole 150 MG Oral Tablet	PSN	8e80f9d8-2577-4fd9-a455-e6c6dc244c3a	1
197700	fluconazole 200 MG Oral Tablet	PSN	8e80f9d8-2577-4fd9-a455-e6c6dc244c3a	1
197700	fluconazole 200 MG Oral Tablet	PSN	15638656-0430-4157-bb13-32ede85131e1	1
197700	fluconazole 200 MG Oral Tablet	PSN	e5beb9cd-aa39-2b37-e053-2995a90a8409	1
197698	fluconazole 100 MG Oral Tablet	SCD	8e80f9d8-2577-4fd9-a455-e6c6dc244c3a	1
197699	fluconazole 150 MG Oral Tablet	SCD	8e80f9d8-2577-4fd9-a455-e6c6dc244c3a	1
197700	fluconazole 200 MG Oral Tablet	SCD	8e80f9d8-2577-4fd9-a455-e6c6dc244c3a	1
197700	fluconazole 200 MG Oral Tablet	SCD	e5beb9cd-aa39-2b37-e053-2995a90a8409	1
197700	fluconazole 200 MG Oral Tablet	SCD	15638656-0430-4157-bb13-32ede85131e1	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-104-10	68462010410	1000 TABLET in 1 BOTTLE (68462-104-10)	1000 tablet	2006-01-25	0000-00-00	No	No	Current
68462-104-30	68462010430	30 TABLET in 1 BOTTLE (68462-104-30)	30 tablet	2006-01-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets	PD-Rx Pharmaceuticals, Inc.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	32
Fluconazole Tablets	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-29	HUMAN PRESCRIPTION DRUG LABEL	23
Fluconazole	Direct Rx	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	6
Fluconazole Tablets	NuCare Pharmaceuticals,Inc.	2022-08-08	HUMAN PRESCRIPTION DRUG LABEL	1
Fluconazole Tablets USP, for oral use rx only	Proficient Rx LP	2022-08-01	HUMAN PRESCRIPTION DRUG LABEL	4
Fluconazole Tablets USP	Dispensing Solutions, Inc. \| PSS World Medical, Inc.	2012-10-01	HUMAN PRESCRIPTION DRUG LABEL	2
Fluconazole Tablets USP	Rebel Distributors Corp	2010-09-27	HUMAN PRESCRIPTION DRUG LABEL	1
Fluconazole Tablets USP	Blenheim Pharmacal, Inc.	2010-09-10	HUMAN PRESCRIPTION DRUG LABEL	1

Fluconazole

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#