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  4. NDC Product Code: 0121-2106 Leuprolide Acetate

NDC 0121-2106 Leuprolide Acetate

Kit Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0121-2106?
  4. Leuprolide Acetate Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

Get all the details for National Drug Code (NDC) 0121-2106 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0121-2106
Proprietary Name:
Leuprolide Acetate
Non-Proprietary Name: [1]
Leuprolide Acetate
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.
Administration Route(s): [4]
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Labeler Name: [5]
Pai Holdings, Llc Dba Pai Pharma
Labeler Code:
0121
Product Label ID:
19be0b7f-e68a-4547-9e49-b51b12821907
FDA Application Number: [6]
ANDA217957
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
02-01-2025
Listing Expiration Date: [11]
12-31-2025
Exclude Flag: [12]
N
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Product Details

What is NDC 0121-2106?

The NDC code 0121-2106 is assigned by the FDA to the product Leuprolide Acetate which is a human prescription drug product labeled by Pai Holdings, Llc Dba Pai Pharma. The product's dosage form is kit and is administered via subcutaneous form. The product is distributed in a single package with assigned NDC code 0121-2106-02 1 kit in 1 carton * 1 vial, multi-dose in 1 carton (0121-1053-02) / 2.8 ml in 1 vial, multi-dose * 1 ml in 1 packet (0121-2105-01). 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 Leuprolide Acetate?

Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment. Leuprolide is also used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

Which are Leuprolide Acetate UNII Codes?

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

Which are Leuprolide Acetate 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 Leuprolide Acetate?

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

[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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".