Premarin Injection, Powder, Lyophilized, For Solution
NDC 0046-0749

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0046-0749?
  4. Premarin Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

Premarin (conjugated estrogens) is a NDA-approved product labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. This medication is a female hormone. It is supplied as a injection, powder, lyophilized, for solution for intramuscular; intravenous administration. This product entry covers the primary NDC 0046-0749 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0046-0749
Proprietary Name:
Premarin
Non-Proprietary Name: [1]
Conjugated Estrogens
Substance Name: [2]
Estrogens, Conjugated
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route(s): [4]
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.

Labeler & Regulatory Data

Labeler Name: [5]
Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Labeler Code:
0046
Product Label ID:
87e2da8d-432c-4ed5-67a1-dc26294b2295
HCPCS Code:
J1410 - INJECTION, ESTROGEN CONJUGATED, PER 25 MG
FDA Application Number: [6]
NDA010402
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-01-1956
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0046-0749?

The NDC code 0046-0749 is assigned by the FDA to the product Premarin. It is commonly known by its generic name, conjugated estrogens. This pharmaceutical product is labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. and is currently categorized as listed product. The medication is a injection, powder, lyophilized, for solution administered via intramuscular; intravenous route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0046-0749-05. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is a female hormone. It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. Certain estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment. Certain estrogen products may also be used by men and women to treat cancers (certain types of prostate cancer, breast cancer that has spread to other parts of the body) and by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure).

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ESTROGENS, CONJUGATED 25 mg/5mL - A pharmaceutical preparation containing a mixture of water-soluble, conjugated estrogens derived wholly or in part from URINE of pregnant mares or synthetically from ESTRONE and EQUILIN. It contains a sodium-salt mixture of estrone sulfate (52-62%) and equilin sulfate (22-30%) with a total of the two between 80-88%. Other concomitant conjugates include 17-alpha-dihydroequilin, 17-alpha-estradiol, and 17-beta-dihydroequilin. The potency of the preparation is expressed in terms of an equivalent quantity of sodium estrone sulfate.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Estrogen Injection


The estradiol cypionate and estradiol valerate forms of estrogen injection are used to treat hot flushes (hot flashes; sudden strong feelings of heat and sweating) and/or vaginal dryness, itching, and burning in women who are experiencing menopause (change of life; the end of monthly menstrual periods). However, women who need a medication only to treat vaginal dryness, itching, or burning should consider a different treatment. These forms of estrogen injection are also sometimes used to treat the symptoms of low estrogen in young women who do not produce enough estrogen naturally. The estradiol valerate form of estrogen injection is also sometimes used to relieve the symptoms of certain types of prostate (a male reproductive organ) cancer. The conjugated estrogens form of estrogen injection is used to treat abnormal vaginal bleeding that a doctor has decided is caused only by a problem with the amounts of certain hormones in the body. Estrogen injection is in a class of medications called hormones. It works by replacing estrogen that is normally produced by the body.
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Product & Regulatory Definitions
What 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.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What 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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What 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.
What 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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".