Fluconazole

Product NDC: 57237-150
11-digit product format: 572370150
Labeler code: 57237
Product ID: 57237-150_8c4429e6-5542-4bec-9d50-1021ea548c01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluconazole
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA079150
Marketing category: ANDA
Marketing start: 2009-09-18
Substance: FLUCONAZOLE
Active strength: 40 mg/mL
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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
FLUCONAZOLE	40 mg/mL

Field, Values table
Field	Values
Unii	8VZV102JFY
Rxcui	310352, 310353

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57237-150-35	Fluconazole	1 in 1 CARTON	POWDER, FOR SUSPENSION	1		16
57237-150-35	Fluconazole	35 mL in 1 BOTTLE	POWDER, FOR SUSPENSION	35		16

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57237-150	FLUCONAZOLE POWDER, FOR SUSPENSION [RISING PHARMA HOLDINGS, INC.]	16	Current NDC, Legacy NDC, 2 package rows	20240827_ccbe0991-27a1-4ddb-bfc7-1b3422e53390.zip

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

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310352	fluconazole 10 MG in 1 mL Oral Suspension	PSN	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310353	fluconazole 40 MG in 1 mL Oral Suspension	PSN	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310352	fluconazole 10 MG/ML Oral Suspension	SCD	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310353	fluconazole 40 MG/ML Oral Suspension	SCD	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310352	fluconazole 10 MG per 1 ML Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310352	fluconazole 10 MG per ML Powder for Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310353	fluconazole 1400 MG per 35 ML Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310353	fluconazole 200 MG per 5 ML Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310352	fluconazole 350 MG per 35 ML Powder for Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310353	fluconazole 40 MG per 1 ML Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310353	fluconazole 40 MG per ML Powder for Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16
310352	fluconazole 50 MG per 5 ML Powder for Oral Suspension	SY	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	16

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57237-150-35	57237015035	1 BOTTLE in 1 CARTON (57237-150-35) / 35 mL in 1 BOTTLE	1 bottle	2009-09-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluconazole for Oral Suspension USP Rx only	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2024-08-22	Human Prescription Drug Label	16