leuprolide acetate

Generic: leuprolide acetate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler sandoz inc
Dosage Form KIT
Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-4003
Product ID 0781-4003_7aa17317-d8ab-485f-8eca-5ef7fc4c6c9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074728
Listing Expiration 2026-12-31
Marketing Start 1998-08-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07814003
Hyphenated Format 0781-4003

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 ANDA074728 (source: ndc)

Resolved Composition

Strengths
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
source: ndc

Packages (1)

0781-4003-32 1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET

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 
{"spl_id": "7aa17317-d8ab-485f-8eca-5ef7fc4c6c9b", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["8bd72c1e-2751-4498-a346-bc5e3acbba0b"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (0781-4003-32)  *  1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET", "package_ndc": "0781-4003-32", "marketing_start_date": "19980804"}], "brand_name": "Leuprolide Acetate", "product_id": "0781-4003_7aa17317-d8ab-485f-8eca-5ef7fc4c6c9b", "dosage_form": "KIT", "product_ndc": "0781-4003", "generic_name": "Leuprolide Acetate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leuprolide Acetate", "application_number": "ANDA074728", "marketing_category": "ANDA", "marketing_start_date": "19980804", "listing_expiration_date": "20261231"}