Drug Information

Product NDC: 0074-3093

Proprietary Name: Viekira Pak

Non Proprietary Name: Dasabuvir and Ombitasvir and Paritaprevir and Ritonavir

Active Ingredient(s):

Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: AbbVie Inc.
FDA Application Number: NDA206619
Marketing Category: NDA
Start Marketing Date:12/19/2014

Package Information

No. Package Code Package Description Billing Unit
10074-3093-011 DOSE PACK in 1 CARTON (0074-3093-01) > 1 KIT in 1 DOSE PACK
20074-3093-284 CARTON in 1 CARTON (0074-3093-28) > 7 DOSE PACK in 1 CARTON > 1 KIT in 1 DOSE PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0074-3093The 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.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEViekira PakThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEDasabuvir and Ombitasvir and Paritaprevir and RitonavirThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEKITThe translation of the dosage form Code submitted by the firm.
START MARKETING DATE12/19/2014This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct 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 NUMBERNDA206619This 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 NAMEAbbVie Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/20/2020