Fluconazole

Product NDC: 50090-6751
11-digit product format: 500906751
Labeler code: 50090
Product ID: 50090-6751_9f34499a-080f-468e-b136-9e425ea07912
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA077731
Marketing category: ANDA
Marketing start: 2008-10-07
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 50090-6751_9f34499a-080f-468e-b136-9e425ea07912
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Fluconazole
Generic name: Fluconazole
Dosage form: TABLET
Route: ORAL
Marketing start: 2008-10-07
Marketing category: ANDA
Application number: ANDA077731
Pharmacologic classes: Azole Antifungal [EPC]; Azoles [CS]; Cytochrome P450 2C19 Inhibitors [MoA]; Cytochrome P450 2C9 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
FLUCONAZOLE	200 mg/1

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

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-6751-0	50090675100	28 TABLET in 1 BOTTLE (50090-6751-0)	28 tablet	2023-10-16	No	No	Current
50090-6751-1	50090675101	30 TABLET in 1 BOTTLE (50090-6751-1)	30 tablet	2023-10-24	No	No	Current
50090-6751-3	50090675103	2 TABLET in 1 BOTTLE (50090-6751-3)	2 tablet	2023-10-24	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets USP Rx only	A-S Medication Solutions	2025-12-01	Human Prescription Drug Label	5