Leuprolide Acetate Powder
NDC Package 41701-013-52
Package Information
Leuprolide Acetate powders is leuprolide is used to treat advanced prostate cancer in men. This formulation utilizes a powder delivery system. Marketed by Piramal Pharma Limited, this product is identified by NDC 41701-013.
Identification & Billing
Clinical Specifications
- LEUPROLIDE ACETATE 135 g/135g
- LEUPROLIDE ACETATE 164 g/164g
- LEUPROLIDE ACETATE 170 g/170g
- LEUPROLIDE ACETATE 221 g/221g
- LEUPROLIDE ACETATE 142 g/142g
- LEUPROLIDE ACETATE 257 g/257g
- LEUPROLIDE ACETATE 80 g/80g
- LEUPROLIDE ACETATE 286 g/286g
- LEUPROLIDE ACETATE 180 g/180g
- LEUPROLIDE ACETATE 252 g/252g
- LEUPROLIDE ACETATE 100 g/100g
- LEUPROLIDE ACETATE 57 g/57g
- LEUPROLIDE ACETATE 86.5 g/86.5g
- LEUPROLIDE ACETATE 240 g/240g
- LEUPROLIDE ACETATE 74 g/74g
- LEUPROLIDE ACETATE 217 g/217g
- LEUPROLIDE ACETATE 37 g/37g
- LEUPROLIDE ACETATE 119 g/119g
- LEUPROLIDE ACETATE 150 g/150g
- LEUPROLIDE ACETATE 64 g/64g
- LEUPROLIDE ACETATE 87.5 g/87.5g
- LEUPROLIDE ACETATE 243 g/243g
- LEUPROLIDE ACETATE 222 g/222g
- LEUPROLIDE ACETATE 139 g/139g
- LEUPROLIDE ACETATE 232 g/232g
- LEUPROLIDE ACETATE 295 g/295g
- LEUPROLIDE ACETATE 96 g/96g
- LEUPROLIDE ACETATE 215 g/215g
- LEUPROLIDE ACETATE 198 g/198g
- LEUPROLIDE ACETATE 157 g/157g
- LEUPROLIDE ACETATE 154 g/154g
- LEUPROLIDE ACETATE 139 g/139g
- LEUPROLIDE ACETATE 156 g/156g
- LEUPROLIDE ACETATE 111 g/111g
- LEUPROLIDE ACETATE 10 g/10g
- LEUPROLIDE ACETATE 250 g/250g
Regulatory & Marketing
Hierarchy Structure
- 41701 - Piramal Pharma Limited
- 41701-013 -
- 41701-013-52 - 1 BOTTLE in 1 BOTTLE / 100 g in 1 BOTTLE (41701-013-51)
- 41701-013 -
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Other Available Packages
The following commercial packages are registered under the same Product NDC (41701-013). Click a package code to view its specific billing and regulatory data.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 41701-013-52 identifies a specific commercial package of 1 bottle in 1 bottle / 100 g in 1 bottle (41701-013-51) of Leuprolide Acetate (UNFINISHED drug), a bulk ingredient labeled by Piramal Pharma Limited. This powder is formulated for use and contains leuprolide acetate as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Piramal Pharma Limited on March 18, 2011. The current certification is valid through December 31, 2026.
What are the primary indications for this medication?
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.
How is this Piramal Pharma Limited product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 41701001352. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
