0049-3190 NDC - VFEND ()

Drug Information

Product NDC: 0049-3190
Proprietary Name: VFEND
Non Proprietary Name:
Active Ingredient(s): 10 mg/mL VORICONAZOLE10 mg/mL VORICONAZOLE
Administration Route(s):
Dosage Form(s):
Pharmacy Class(es): Azole Antifungal [EPC]; Azoles [CS]; Cytochrome P450 2C19 Inhibitors [MoA]; Cytochrome P450 2C9 Inhibitors [MoA]; Cytochrome P450 3A4 Inhibitors [MoA]

Labeler Information

Field Name	Field Value
Labeler Name:	Roerig
Product Type:
FDA Application Number:	NDA021267
Marketing Category:	NDA
Start Marketing Date:	10/24/2012
End Marketing Date:	11/30/2022

Package Information

No.	Package Code	Package Description	Billing Unit
1	0049-3190-01	1 VIAL, SINGLE-USE in 1 CARTON (0049-3190-01) / 20 mL in 1 VIAL, SINGLE-USE	EA
2	0049-3190-28	1 VIAL, SINGLE-DOSE in 1 CARTON (0049-3190-28) / 20 mL in 1 VIAL, SINGLE-DOSE	EA
3	0049-3190-38	20 mL in 1 VIAL, SINGLE-USE (0049-3190-38)	EA

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	0049-3190	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME	VFEND	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	10/24/2012	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	NDA021267	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Roerig	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	0049-3190	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME	VFEND	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	5/24/2002	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	NDA021267	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Roerig	Name of Company corresponding to the labeler code segment of the Product NDC.
PRODUCT NDC	0049-3190	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAME	VFEND	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	3/28/2003	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	NDA	Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBER	NDA021267	This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAME	Roerig	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/26/2025

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