1. Labeler Index
  2. Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
  3. NDC Product Code: 0046-1105 Prempro

NDC 0046-1105 Prempro

Conjugated Estrogens And Medroxyprogesterone Acetate Tablet, Sugar Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. Product Characteristics
    4. What is NDC 0046-1105?
    5. Prempro Uses
    6. Active Ingredients
    7. Active Ingredients UNII Codes
    8. Inactive Ingredients UNII Codes
    9. NDC to RxNorm Crosswalk
    10. Pharmacologic Classes
    11. Patient Education

Product Information

NDC Product Code:
0046-1105
Proprietary Name:
Prempro
Non-Proprietary Name: [1]
Conjugated Estrogens And Medroxyprogesterone Acetate
Substance Name: [2]
Estrogens, Conjugated; Medroxyprogesterone Acetate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Sugar Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a colored or an uncolored water-soluble sugar.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.
    Labeler Code:
    0046
    Product Label ID:
    fd0c0836-5d23-2183-da81-9dc7f4287052
    FDA Application Number: [6]
    NDA020527
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    09-21-2009
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - LIGHT BLUE)
    BROWN (C48332 - MAROON)
    YELLOW (C48330 - CREAM)
    Shape:
    OVAL (C48345)
    Size(s):
    10 MM
    Imprint(s):
    PREMPRO;0625;5
    PREMARIN;0625
    PREMPRO;03;15
    Score:
    1

    Product Packages

    NDC Code 0046-1105-11

    Package Description: 1 BLISTER PACK in 1 CARTON / 28 TABLET, SUGAR COATED in 1 BLISTER PACK

    Price per Unit: $8.02907 per EA

    Product Details

    What is NDC 0046-1105?

    The NDC code 0046-1105 is assigned by the FDA to the product Prempro which is a human prescription drug product labeled by Wyeth Pharmaceuticals Llc, A Subsidiary Of Pfizer Inc.. The generic name of Prempro is conjugated estrogens and medroxyprogesterone acetate. The product's dosage form is tablet, sugar coated and is administered via oral form. The product is distributed in a single package with assigned NDC code 0046-1105-11 1 blister pack in 1 carton / 28 tablet, sugar coated in 1 blister pack. 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 Prempro?

    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.

    What are Prempro 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.
    • ESTROGENS, CONJUGATED .3 mg/1 - A pharmaceutical preparation containing a mixture of water-soluble, conjugated estrogens derived wholly or in part from URINE of pregnant mares or synthetically from ESTRONE and EQUILIN. It contains a sodium-salt mixture of estrone sulfate (52-62%) and equilin sulfate (22-30%) with a total of the two between 80-88%. Other concomitant conjugates include 17-alpha-dihydroequilin, 17-alpha-estradiol, and 17-beta-dihydroequilin. The potency of the preparation is expressed in terms of an equivalent quantity of sodium estrone sulfate.
    • MEDROXYPROGESTERONE ACETATE 1.5 mg/1 - 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 Prempro UNII Codes?

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

    • ESTROGENS, CONJUGATED (UNII: IU5QR144QX)
    • ESTROGENS, CONJUGATED (UNII: IU5QR144QX) (Active Moiety)
    • MEDROXYPROGESTERONE ACETATE (UNII: C2QI4IOI2G)
    • MEDROXYPROGESTERONE (UNII: HSU1C9YRES) (Active Moiety)

    Which are Prempro 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 Prempro?

    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: 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

    Which are the Pharmacologic Classes for Prempro?

    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

    Estrogen and Progestin (Hormone Replacement Therapy)


    Combinations of estrogen and progestin are used to treat certain symptoms of menopause. Estrogen and progestin are two female sex hormones. Hormone replacement therapy works by replacing estrogen hormone that is no longer being made by the body. Estrogen reduces feelings of warmth in the upper body and periods of sweating and heat (hot flashes), vaginal symptoms (itching, burning, and dryness) and difficulty with urination, but it does not relieve other symptoms of menopause such as nervousness or depression. Estrogen also prevents thinning of the bones (osteoporosis) in menopausal women. Progestin is added to estrogen in hormone replacement therapy to reduce the risk of uterine cancer in women who still have their uterus.
    [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".