NDC 54868-4230 Prometrium

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-4230
Proprietary Name:
Prometrium
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Start Marketing Date: [9]
11-03-2004
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
ORANGE (C48331 - PEACH)
YELLOW (C48330 - YELLOW)
Shape:
ROUND (C48348)
OVAL (C48345)
Size(s):
13 MM
15 MM
Imprint(s):
SV
SV2
Score:
1

Product Packages

NDC Code 54868-4230-0

Package Description: 30 CAPSULE in 1 BOTTLE

NDC Code 54868-4230-1

Package Description: 10 CAPSULE in 1 BOTTLE

NDC Code 54868-4230-2

Package Description: 5 CAPSULE in 1 BOTTLE

Product Details

What is NDC 54868-4230?

The NDC code 54868-4230 is assigned by the FDA to the product Prometrium which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in 3 packages with assigned NDC codes 54868-4230-0 30 capsule in 1 bottle , 54868-4230-1 10 capsule in 1 bottle , 54868-4230-2 5 capsule in 1 bottle . 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 Prometrium?

Progesterone 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. In women who are not pregnant and not going through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). Progesterone is also used as part of combination hormone replacement therapy with estrogens to reduce menopause symptoms (e.g., hot flashes). Progesterone is added to estrogen replacement therapy to reduce the risk of cancer of the uterus. This medication is not for use in children. Progesterone must not be used to test for pregnancy.

Which are Prometrium UNII Codes?

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

Which are Prometrium 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 Prometrium?

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:

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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".