Premarin Tablet, Film Coated
NDC Package 0046-1102-52

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Premarin (estrogens, conjugated) tablets is a medication a female hormone. This formulation utilizes a tablet, film coated delivery system. Marketed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc., this product is identified by NDC 0046-1102 and is authorized under FDA application NDA004782.

Identification & Billing

NDC Package Code
0046-1102-52
Package Description
1 BLISTER PACK in 1 CARTON / 5 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
0046-1102
11-Digit Billing Format
00046110252
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Premarin
Non-Proprietary Name
Estrogens, Conjugated
Substance Name
Estrogens, Conjugated
Dosage Form
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
ESTROGENS, CONJUGATED .625 mg/1
Pharmacologic Class
Usage Information
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).

Regulatory & Marketing

Labeler Name
Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA004782
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-01-2006
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0046-1102). Click a package code to view its specific billing and regulatory data.

0046-1102-81
100 TABLET, FILM COATED in 1 BOTTLE
0046-1102-91
1 BOTTLE in 1 CARTON / 1000 TABLET, FILM COATED in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0046-1102-52 identifies a specific commercial package of 1 blister pack in 1 carton / 5 tablet, film coated in 1 blister pack of Premarin, a human prescription drug labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. This tablet, film coated is formulated for oral use and contains estrogens, conjugated as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. on January 01, 2006. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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).

How is this Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00046110252. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0046-1102-52
11-Digit CMS (5-4-2)
00046-1102-52

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.