Provera Tablet
NDC Package 0009-0065-01

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

Package Information

Provera (medroxyprogesterone acetate) tablets is medroxyprogesterone is a type of female hormone (progestin). This formulation utilizes a tablet delivery system. Marketed by Pharmacia & Upjohn Company Llc, this product is identified by NDC 0009-0065 and is authorized under FDA application NDA011839.

Identification & Billing

NDC Package Code
0009-0065-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
0009-0065
11-Digit Billing Format
00009006501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Provera
Non-Proprietary Name
Medroxyprogesterone Acetate
Substance Name
Medroxyprogesterone Acetate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MEDROXYPROGESTERONE ACETATE 2.5 mg/1
Pharmacologic Class
Usage Information
Medroxyprogesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. This medication has several uses. In women who are not pregnant and not going through menopause, this medication is used to treat abnormal bleeding from the uterus and to restore normal menstrual periods in women who have stopped having them for several months (amenorrhea). Medroxyprogesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Medroxyprogesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication must not be used to test for pregnancy.

Regulatory & Marketing

Labeler Name
Pharmacia & Upjohn Company Llc
Product Type
Human Prescription Drug
FDA Application #
NDA011839
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-03-2019
Listing Expiration
12-31-2026
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 0009-0065-01 identifies a specific commercial package of 100 tablet in 1 bottle of Provera, a human prescription drug labeled by Pharmacia & Upjohn Company Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains medroxyprogesterone acetate 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 Pharmacia & Upjohn Company Llc on September 03, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Medroxyprogesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes and is given to replace the hormone when your body is not making enough of it. This medication has several uses. In women who are not pregnant and not going through menopause, this medication is used to treat abnormal bleeding from the uterus and to restore normal menstrual periods in women who have stopped having them for several months (amenorrhea). Medroxyprogesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Medroxyprogesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication must not be used to test for pregnancy.

How is this Pharmacia & Upjohn Company Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00009006501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
0009-0065-01
11-Digit CMS (5-4-2)
00009-0065-01

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