leuprolide acetate

Generic: leuprolide acetate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler amneal pharmaceuticals llc
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-2537
Product ID 70121-2537_9a91921e-6c03-429b-94b5-6d885f3fe364
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215336
Listing Expiration 2026-12-31
Marketing Start 2022-11-07

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701212537
Hyphenated Format 70121-2537

Supplemental Identifiers

RxCUI
545835 797544

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name leuprolide acetate (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number ANDA215336 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70121-2538-9)
source: ndc

Packages (1)

70121-2537-6 1 KIT in 1 CARTON (70121-2537-6) * 1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (70121-2538-9)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

leuprolide acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "9a91921e-6c03-429b-94b5-6d885f3fe364", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["4838c674-044e-46b2-81e7-c691b99d8fa5"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (70121-2537-6)  *  1 VIAL, MULTI-DOSE in 1 CARTON (70121-1695-2)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET (70121-2538-9)", "package_ndc": "70121-2537-6", "marketing_start_date": "20221107"}], "brand_name": "leuprolide acetate", "product_id": "70121-2537_9a91921e-6c03-429b-94b5-6d885f3fe364", "dosage_form": "KIT", "product_ndc": "70121-2537", "generic_name": "leuprolide acetate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leuprolide acetate", "application_number": "ANDA215336", "marketing_category": "ANDA", "marketing_start_date": "20221107", "listing_expiration_date": "20261231"}