0046-2575 NDC - PREMPHASE (CONJUGATED ESTROGENS AND MEDROXYPROGESTERONE ACETATE)

Drug Information

Product NDC: 0046-2575

Proprietary Name: Premphase

Non Proprietary Name: conjugated estrogens and medroxyprogesterone acetate

Active Ingredient(s):


Administration Route(s):

Dosage Form(s): KIT

Labeler Information

Labeler Name: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020527
Marketing Category: NDA
Start Marketing Date:3/1/2012

Package Information

No. Package Code Package Description Billing Unit
10046-2575-121 BLISTER PACK in 1 CARTON (0046-2575-12) > 1 KIT in 1 BLISTER PACKEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0046-2575The 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 NAMEPremphaseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEconjugated estrogens and medroxyprogesterone acetateThe 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 DATE3/1/2012This 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 NUMBERNDA020527This 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 NAMEWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 9/15/2022