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  4. NDC Product Code: 54868-4997 Pregnyl

NDC 54868-4997 Pregnyl

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 54868-4997?
  4. Pregnyl Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
54868-4997
Proprietary Name:
Pregnyl
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Physicians Total Care, Inc.
Labeler Code:
54868
Product Label ID:
dc604794-6dd6-43a7-85fa-2f04ed325c33
Start Marketing Date: [9]
08-17-2010
Listing Expiration Date: [11]
12-31-2017
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 54868-4997-0

Package Description: 1 KIT in 1 CARTON * 10 mL in 1 VIAL * 10 mL in 1 VIAL, MULTI-DOSE

Product Details

What is NDC 54868-4997?

The NDC code 54868-4997 is assigned by the FDA to the product Pregnyl which is product labeled by Physicians Total Care, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 54868-4997-0 1 kit in 1 carton * 10 ml in 1 vial * 10 ml in 1 vial, multi-dose. 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 Pregnyl?

This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (e.g., testosterone). This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in women whose ovaries no longer make eggs properly (primary ovarian failure). This medication has not been shown to be effective for weight loss and should not be used for this purpose due to risk of serious side effects.

Which are Pregnyl UNII Codes?

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

  • CHORIOGONADOTROPIN ALFA (UNII: 6413W06WR3)
  • CHORIOGONADOTROPIN ALFA (UNII: 6413W06WR3) (Active Moiety)

Which are Pregnyl 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 Pregnyl?

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: 896854 - chorionic gonadotropin 10,000 UNT/ML Injectable Solution
  • RxCUI: 896854 - chorionic gonadotropin 10000 UNT/ML Injectable Solution
  • RxCUI: 896856 - Pregnyl 10,000 UNT/ML Injectable Solution
  • RxCUI: 896856 - chorionic gonadotropin 10000 UNT/ML Injectable Solution [Pregnyl]

* Please review the disclaimer below.

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".