Drug Information

Product NDC: 0603-7512

Proprietary Name: Kimidess

Non Proprietary Name: desogestrel and ethinyl estradiol

Active Ingredient(s):

Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: Par Pharmaceutical
FDA Application Number: ANDA076681
Marketing Category: ANDA
Start Marketing Date:6/8/2015
End Marketing Date:1/31/2021

Package Information

No. Package Code Package Description Billing Unit
10603-7512-176 BLISTER PACK in 1 CARTON (0603-7512-17) > 1 KIT in 1 BLISTER PACK (0603-7512-01) * 21 TABLET, FILM COATED in 1 BLISTER PACK * 5 TABLET, FILM COATED in 1 BLISTER PACKEA
20603-7512-493 BLISTER PACK in 1 CARTON (0603-7512-49) > 1 KIT in 1 BLISTER PACK (0603-7512-01) * 21 TABLET, FILM COATED in 1 BLISTER PACK * 5 TABLET, FILM COATED in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0603-7512The 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 NAMEKimidessThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEdesogestrel 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 DATE6/8/2015This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE1/31/2021This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
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 NUMBERANDA076681This 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 NAMEPar PharmaceuticalName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 5/29/2020