NDC 0008-0045 Vinorelbine Tartrate

Vinorelbine Tartrate

NDC Product Code 0008-0045

NDC Code: 0008-0045

Proprietary Name: Vinorelbine Tartrate Additional informationCallout TooltipWhat is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Vinorelbine Tartrate Additional informationCallout TooltipWhat is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.


Code Structure
  • 0008 - Wyeth Pharmaceuticals Company
    • 0008-0045 - Vinorelbine Tartrate

NDC 0008-0045-01

Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON > 1 mL in 1 VIAL, SINGLE-DOSE

NDC 0008-0045-02

Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON > 5 mL in 1 VIAL, SINGLE-DOSE

NDC Product Information

Vinorelbine Tartrate with NDC 0008-0045 is a a human prescription drug product labeled by Wyeth Pharmaceuticals Company. The generic name of Vinorelbine Tartrate is vinorelbine tartrate. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: Wyeth Pharmaceuticals Company

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug Additional informationCallout TooltipWhat kind of product is this?
Indicates 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.


Vinorelbine Tartrate Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • VINORELBINE TARTRATE 10 mg/mL

Administration Route(s)

Additional informationCallout TooltipWhat are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

Additional informationCallout TooltipWhat is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Vinca Alkaloid - [EPC] (Established Pharmacologic Class)
  • Vinca Alkaloids - [CS]
  • Vinca Alkaloid - [EPC] (Established Pharmacologic Class)
  • Vinca Alkaloids - [CS]

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Wyeth Pharmaceuticals Company
Labeler Code: 0008
FDA Application Number: ANDA178408 Additional informationCallout TooltipWhat is the FDA Application Number?
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.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. Additional informationCallout TooltipWhat is the Marketing Category?
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.

Start Marketing Date: 02-13-2008 Additional informationCallout TooltipWhat is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 Additional informationCallout TooltipWhat is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: E Additional informationCallout TooltipWhat is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

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