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  4. NDC Product Code: 69189-1107 Prempro

NDC 69189-1107 Prempro

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 69189-1107?
  5. Prempro Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
69189-1107
Proprietary Name:
Prempro
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Avera Mckennan Hospital
Labeler Code:
69189
Product Label ID:
62551977-a89a-4a97-bdf1-ef74868d3c1a
Start Marketing Date: [9]
01-28-2016
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - PEACH)
Shape:
OVAL (C48345)
Size(s):
10 MM
Imprint(s):
PREMPRO;0625;25
Score:
1

Code Structure Chart

Product Details

What is NDC 69189-1107?

The NDC code 69189-1107 is assigned by the FDA to the product Prempro which is product labeled by Avera Mckennan Hospital. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69189-1107-1 1 tablet, sugar coated in 1 dose 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.

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:

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Product Footnotes

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

[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".