Fluconazole

Product NDC: 71335-1268
11-digit product format: 713351268
Labeler code: 71335
Product ID: 71335-1268_37401a7b-6d0c-5f6e-e063-6294a90a3e36
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077731
Marketing category: ANDA
Marketing start: 2008-10-07
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: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-1268_37401a7b-6d0c-5f6e-e063-6294a90a3e36
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	150 mg/1

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

Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1268-1	71335126801	1 BLISTER PACK in 1 POUCH (71335-1268-1) / 1 TABLET in 1 BLISTER PACK	1 blister pack	2008-10-07	0000-00-00	No	No	Current
71335-1268-2	71335126802	2 BLISTER PACK in 1 POUCH (71335-1268-2) / 1 TABLET in 1 BLISTER PACK	2 blister pack	2008-10-07		No	No	Current
71335-1268-3	71335126803	3 BLISTER PACK in 1 POUCH (71335-1268-3) / 1 TABLET in 1 BLISTER PACK	3 blister pack	2008-10-07		No	No	Current

Title	Manufacturer	Effective date	Type	Version
Fluconazole Tablets USP Rx only	Bryant Ranch Prepack	2025-06-10	HUMAN PRESCRIPTION DRUG LABEL	8