Medroxyprogesterone Acetate Injection, Suspension, Extended Release
NDC 0548-5701

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0548-5701?
  4. Medroxyprogesterone Acetate Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes
  9. Patient Education

Product Information

Medroxyprogesterone Acetate is a ANDA-approved product labeled by Amphastar Pharmaceuticals, Inc.. This medication is used to prevent pregnancy. It is supplied as a injection, suspension, extended release for intramuscular administration. This product entry covers the primary NDC 0548-5701 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0548-5701
Proprietary Name:
Medroxyprogesterone Acetate
Non-Proprietary Name: [1]
Medroxyprogesterone Acetate
Substance Name: [2]
Medroxyprogesterone Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Injection, Suspension, Extended Release - A sterile preparation intended for parenteral use which has been formulated in a manner to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form (e.g., as a solution or a prompt drug-releasing, conventional solid dosage form).
Administration Route(s): [4]
Intramuscular - Administration within a muscle.

Labeler & Regulatory Data

Labeler Name: [5]
Amphastar Pharmaceuticals, Inc.
Labeler Code:
0548
Product Label ID:
fda1aa8a-5739-482a-b4f6-9741ef4d9977
HCPCS Code:
J1050 - INJECTION, MEDROXYPROGESTERONE ACETATE, 1 MG
FDA Application Number: [6]
ANDA077334
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
11-28-2017
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 0548-5701?

The NDC code 0548-5701 is assigned by the FDA to the product Medroxyprogesterone Acetate. This pharmaceutical product is labeled by Amphastar Pharmaceuticals, Inc. and is currently categorized as listed product. The medication is a injection, suspension, extended release administered via intramuscular route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 0548-5701-00. 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 used to prevent pregnancy. Medroxyprogesterone is like a natural hormone made by the body. It works mainly by preventing the growth and release of an egg (ovulation) during your menstrual cycle. It also makes vaginal fluid thicker to help prevent sperm from reaching an egg (fertilization) and changes the lining of the uterus (womb) to prevent attachment of a fertilized egg. Medroxyprogesterone is also used to treat endometriosis. It works by lowering the amount of certain hormones in the body and decreasing the growth of abnormal tissues that cause endometriosis. This helps reduce pain and other symptoms. Using this medication does not protect you or your partner against sexually transmitted diseases (such as HIV, gonorrhea, chlamydia).

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.
  • MEDROXYPROGESTERONE ACETATE 150 mg/mL - A synthetic progestin that is derived from 17-hydroxyprogesterone. It is a long-acting contraceptive that is effective both orally or by intramuscular injection and has also been used to treat breast and endometrial neoplasms.

Which are the associated UNII Codes?

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

  • MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G)
  • MEDROXYPROGESTERONE (UNII: HSU1C9YRES) (Active Moiety)

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:

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.

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

Patient Education

Medroxyprogesterone Injection


Medroxyprogesterone intramuscular (into a muscle) injection and medroxyprogesterone subcutaneous (under the skin) injection are used to prevent pregnancy. Medroxyprogesterone subcutaneous injection is also used to treat endometriosis (a condition in which the type of tissue that lines the uterus (womb) grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Medroxyprogesterone is in a class of medications called progestins. It works to prevent pregnancy by preventing ovulation (the release of eggs from the ovaries). Medroxyprogesterone also thins the lining of the uterus. This helps to prevent pregnancy in all women and slows the spread of tissue from the uterus to other parts of the body in women who have endometriosis. Medroxyprogesterone injection is a very effective method of birth control but does not prevent the spread of human immunodeficiency virus (HIV, the virus that causes acquired immunodeficiency syndrome [AIDS]) or other sexually transmitted diseases.
[Learn More]


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

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".