Premphase Kit
NDC Package 0046-2575-12

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

Package Information

Premphase (conjugated estrogens and medroxyprogesterone acetate) kits is this medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). This formulation utilizes a kit delivery system. Marketed by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc., this product is identified by NDC 0046-2575 and is authorized under FDA application NDA020527.

Identification & Billing

NDC Package Code
0046-2575-12
Package Description
1 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Code
0046-2575
11-Digit Billing Format
00046257512
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 1000351 - estrogens, conjugated 0.3 MG / medroxyPROGESTERone acetate 1.5 MG Oral Tablet
  • RxCUI: 1000351 - estrogens, conjugated (USP) 0.3 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet
  • RxCUI: 1000352 - estrogens, conjugated 0.45 MG / medroxyPROGESTERone acetate 1.5 MG Oral Tablet
  • RxCUI: 1000352 - estrogens, conjugated (USP) 0.45 MG / medroxyprogesterone acetate 1.5 MG Oral Tablet
  • RxCUI: 1000355 - estrogens, conjugated 0.625 MG / medroxyPROGESTERone acetate 2.5 MG Oral Tablet

Clinical Specifications

Proprietary Name
Premphase
Non-Proprietary Name
Conjugated Estrogens And Medroxyprogesterone Acetate
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). 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. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. 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. This medication 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/progestin treatment.

Regulatory & Marketing

Labeler Name
Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA020527
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-01-2012
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0046-2575-12 identifies a specific commercial package of 1 blister pack in 1 carton / 1 kit in 1 blister pack of Premphase, a human prescription drug labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. This kit is formulated for use and contains 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 March 01, 2012. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication contains 2 female hormones: an estrogen (such as conjugated estrogen, estradiol) and a progestin (such as medroxyprogesterone, norethindrone, norgestimate). 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. The progestin in this medication helps to reduce the risk of cancer of the uterus which can be caused by using estrogen. Women who have had their uterus removed do not need the progestin and therefore should not use this combination medication. 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. This medication 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/progestin treatment.

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: 00046257512. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
0046-2575-12
11-Digit CMS (5-4-2)
00046-2575-12

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