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  2. Merck Sharp & Dohme Llc
  3. NDC Product Code: 0052-0315 Pregnyl

NDC 0052-0315 Pregnyl

Choriogonadotropin Alfa Kit - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0052-0315?
    4. Pregnyl Uses
    5. Active Ingredients UNII Codes
    6. Inactive Ingredients UNII Codes
    7. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
0052-0315
Proprietary Name:
Pregnyl
Non-Proprietary Name: [1]
Choriogonadotropin Alfa
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Kit - A packaged collection of related material.
Labeler Name: [5]
Merck Sharp & Dohme Llc
Labeler Code:
0052
Product Label ID:
3e26b843-9c7a-4517-a1b6-9362aab0b86c
FDA Application Number: [6]
BLA017692
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date: [9]
10-20-1976
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Code Structure:
Code Navigator:

Product Packages

NDC Code 0052-0315-10

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

Price per Unit: $112.31634 per EA

Product Details

What is NDC 0052-0315?

The NDC code 0052-0315 is assigned by the FDA to the product Pregnyl which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Pregnyl is choriogonadotropin alfa. The product's dosage form is kit. The product is distributed in a single package with assigned NDC code 0052-0315-10 1 kit in 1 carton * 10 ml in 1 vial, multi-dose * 10 ml in 1 vial. 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

[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.

[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.

[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".