1. Home
  2. Labeler Index
  3. Amneal Pharmaceuticals Of Ny Llc
  4. NDC Product Code: 69238-1797 Hydroxyprogesterone Caproate

NDC 69238-1797 Hydroxyprogesterone Caproate

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 69238-1797?
  4. Hydroxyprogesterone Caproate 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:
69238-1797
Proprietary Name:
Hydroxyprogesterone Caproate
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Amneal Pharmaceuticals Of Ny Llc
Labeler Code:
69238
Product Label ID:
79cd136b-2098-43a4-aeec-7d8b8869f6ae
Start Marketing Date: [9]
03-11-2019
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Packages

NDC Code 69238-1797-1

Package Description: 1 VIAL in 1 BOX / 1 mL in 1 VIAL

Product Details

What is NDC 69238-1797?

The NDC code 69238-1797 is assigned by the FDA to the product Hydroxyprogesterone Caproate which is product labeled by Amneal Pharmaceuticals Of Ny Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 69238-1797-1 1 vial in 1 box / 1 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 Hydroxyprogesterone Caproate?

This medication is used in women who are pregnant with a single baby, and who have delivered a baby too early (preterm) in the past. It is used to help lower the risk of having a preterm baby again. Hydroxyprogesterone is a man-made form of a female hormone (progestin). It is not known how it works to prevent preterm births. This medication is not intended to prevent preterm birth in women pregnant with more than one baby (such as twins, triplets). It is also not intended to stop active preterm labor.

Which are Hydroxyprogesterone Caproate UNII Codes?

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

  • HYDROXYPROGESTERONE CAPROATE (UNII: 276F2O42F5)
  • HYDROXYPROGESTERONE (UNII: 21807M87J2) (Active Moiety)

Which are Hydroxyprogesterone Caproate 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 Hydroxyprogesterone Caproate?

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: 1796690 - HYDROXYprogesterone caproate 250 MG in 1 ML Injection
  • RxCUI: 1796690 - 1 ML hydroxyprogesterone caproate (USP) 250 MG/ML Injection
  • RxCUI: 1796690 - hydroxyprogesterone caproate 250 MG per 1 ML Injection

* 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".