0781-5584 NDC - INTROVALE (LEVONORGESTREL AND ETHINYL ESTRADIOL)

Drug Information

Product NDC: 0781-5584

Proprietary Name: Introvale

Non Proprietary Name: Levonorgestrel and Ethinyl Estradiol

Active Ingredient(s):


Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: Sandoz Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA079064
Marketing Category: ANDA
Start Marketing Date:9/27/2010

Package Information

No. Package Code Package Description Billing Unit
10781-5584-363 CARTON in 1 BOX (0781-5584-36) > 1 KIT in 1 CARTONEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0781-5584The 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 NAMEIntrovaleThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMELevonorgestrel and Ethinyl EstradiolThe 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 DATE9/27/2010This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA079064This 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 NAMESandoz IncName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 8/16/2019