NDC 0009-4709 Depo-subq Provera

Medroxyprogesterone Acetate Injection, Suspension Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
0009-4709
Proprietary Name:
Depo-subq Provera
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
Dosage Form:
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route(s): [4]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Labeler Code:
    0009
    FDA Application Number: [6]
    NDA021583
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    05-02-2005
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 0009-4709?

    The NDC code 0009-4709 is assigned by the FDA to the product Depo-subq Provera which is a human prescription drug product labeled by Pharmacia & Upjohn Company Llc. The generic name of Depo-subq Provera is medroxyprogesterone acetate. The product's dosage form is injection, suspension and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0009-4709-13 1 syringe in 1 carton / .65 ml in 1 syringe. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Depo-subq Provera?

    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 Depo-subq Provera Active Ingredients?

    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 104 mg/.65mL - 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 Depo-subq Provera UNII Codes?

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

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

    Which are Depo-subq Provera Inactive Ingredients 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 Depo-subq Provera?

    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:
    • RxCUI: 1000156 - medroxyPROGESTERone acetate 104 MG in 0.65 ML Prefilled Syringe
    • RxCUI: 1000156 - 0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe
    • RxCUI: 1000156 - medroxyprogesterone acetate 104 MG per 0.65 ML Prefilled Syringe
    • RxCUI: 1000158 - depo-subQ provera 104 MG in 0.65 ML Prefilled Syringe
    • RxCUI: 1000158 - 0.65 ML medroxyprogesterone acetate 160 MG/ML Prefilled Syringe [depo-subQ provera]

    Which are the Pharmacologic Classes for Depo-subq Provera?

    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 disclaimer below.

    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 disclaimer below.

    Product Footnotes

    [1] 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.

    [2] 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.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".