1. Home
  2. Labeler Index
  3. Piramal Pharma Limited
  4. NDC Product Code: 41701-013 Leuprolide Acetate

NDC 41701-013 Leuprolide Acetate

Powder - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 41701-013?
  4. Leuprolide Acetate Uses
  5. Active Ingredients

Product Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.
NDC Product Code:
41701-013
Proprietary Name:
Leuprolide Acetate
Non-Proprietary Name: [1]
Leuprolide Acetate
Substance Name: [2]
Leuprolide Acetate
NDC Directory Status:
Bulk Ingredient
Product Type: [3]
UNFINISHED PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
Labeler Name: [5]
Piramal Pharma Limited
Labeler Code:
41701
Marketing Category: [8]
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date: [9]
03-18-2011
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
N
Unfinished Product: [13]
Yes
Code Navigator:

Code Structure Chart

Product Details

What is NDC 41701-013?

The NDC code 41701-013 is assigned by the FDA to the UNFINISHED product Leuprolide Acetate which is a bulk ingredient product labeled by Piramal Pharma Limited. The generic name of Leuprolide Acetate is leuprolide acetate. The product's dosage form is powder. The product is distributed in 36 packages with assigned NDC codes 41701-013-10 1 bottle in 1 bottle / 250 g in 1 bottle (41701-013-09), 41701-013-12 1 bottle in 1 bottle / 139 g in 1 bottle (41701-013-11), 41701-013-20 1 bottle in 1 bottle / 252 g in 1 bottle (41701-013-19), 41701-013-24 1 bottle in 1 bottle / 217 g in 1 bottle (41701-013-23), 41701-013-26 1 bottle in 1 bottle / 295 g in 1 bottle (41701-013-25), 41701-013-30 1 bottle in 1 bottle / 10 g in 1 bottle (41701-013-29), 41701-013-38 1 bottle in 1 bottle / 257 g in 1 bottle (41701-013-37), 41701-013-40 1 bottle in 1 bottle / 243 g in 1 bottle (41701-013-39), 41701-013-42 1 bottle in 1 bottle / 50 g in 1 bottle (41701-013-41), 41701-013-44 1 bottle in 1 bottle / 87.5 g in 1 bottle (41701-013-43), 41701-013-46 1 bottle in 1 bottle / 139 g in 1 bottle (41701-013-45), 41701-013-48 1 bottle in 1 bottle / 286 g in 1 bottle (41701-013-47), 41701-013-50 1 bottle in 1 bottle / 222 g in 1 bottle (41701-013-49), 41701-013-52 1 bottle in 1 bottle / 100 g in 1 bottle (41701-013-51), 41701-013-54 1 bottle in 1 bottle / 111 g in 1 bottle (41701-013-53), 41701-013-57 1 bottle in 1 bottle / 156 g in 1 bottle (41701-013-56), 41701-013-60 1 bottle in 1 bottle / 86.5 g in 1 bottle (41701-013-59), 41701-013-62 1 bottle in 1 bottle / 135 g in 1 bottle (41701-013-61), 41701-013-64 1 bottle in 1 bottle / 57 g in 1 bottle (41701-013-63), 41701-013-66 1 bottle in 1 bottle / 170 g in 1 bottle (41701-013-65), 41701-013-68 1 bottle in 1 bottle / 157 g in 1 bottle (41701-013-67), 41701-013-70 1 bottle in 1 bottle / 154 g in 1 bottle (41701-013-69), 41701-013-72 1 bottle in 1 bottle / 37 g in 1 bottle (41701-013-71), 41701-013-74 1 bottle in 1 bottle / 180 g in 1 bottle (41701-013-73), 41701-013-76 1 bottle in 1 bottle / 80 g in 1 bottle (41701-013-75), 41701-013-78 1 bottle in 1 bottle / 232 g in 1 bottle (41701-013-77), 41701-013-80 1 bottle in 1 bottle / 240 g in 1 bottle (41701-013-79), 41701-013-82 1 bottle in 1 bottle / 74 g in 1 bottle (41701-013-81), 41701-013-84 1 bottle in 1 bottle / 64 g in 1 bottle (41701-013-83), 41701-013-86 1 bottle in 1 bottle / 96 g in 1 bottle (41701-013-85), 41701-013-88 1 bottle in 1 bottle / 164 g in 1 bottle (41701-013-87), 41701-013-90 1 bottle in 1 bottle / 198 g in 1 bottle (41701-013-89), 41701-013-92 1 bottle in 1 bottle / 215 g in 1 bottle (41701-013-91), 41701-013-94 1 bottle in 1 bottle / 221 g in 1 bottle (41701-013-93), 41701-013-96 1 bottle in 1 bottle / 119 g in 1 bottle (41701-013-95), 41701-013-98 1 bottle in 1 bottle / 142 g in 1 bottle (41701-013-97). 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.

What are Leuprolide Acetate Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • LEUPROLIDE ACETATE 135 g/135g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 164 g/164g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 170 g/170g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 221 g/221g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 142 g/142g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 257 g/257g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 80 g/80g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 286 g/286g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 180 g/180g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 252 g/252g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 100 g/100g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 57 g/57g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 86.5 g/86.5g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 50 g/50g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 240 g/240g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 74 g/74g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 217 g/217g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 37 g/37g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 119 g/119g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 64 g/64g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 87.5 g/87.5g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 243 g/243g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 222 g/222g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 139 g/139g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 232 g/232g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 295 g/295g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 96 g/96g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 215 g/215g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 198 g/198g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 157 g/157g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 154 g/154g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 139 g/139g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 156 g/156g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 111 g/111g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 10 g/10g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • LEUPROLIDE ACETATE 250 g/250g - A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.

* 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.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[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.

[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".

[13] What is an Unfinished Product? - This field indicates if the product is an unfinished drug. An unfinished drug is an active pharmaceutical ingredient either alone or with other ingredients that is not a finished drug product. Unfinished drugs are used to process other drugs or for drug compounding.