leuprolide acetate

Generic: leuprolide acetate

Labeler: meitheal pharmaceuticals inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler meitheal pharmaceuticals inc
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Meitheal Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 71288-569
Product ID 71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA075471
Listing Expiration 2026-12-31
Marketing Start 2024-05-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71288569
Hyphenated Format 71288-569

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 ANDA075471 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/0.2 ml
  • 14 mg/2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)
source: ndc

Packages (1)

71288-569-90 1 KIT in 1 CARTON (71288-569-90) * 1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03) / 2.8 mL in 1 VIAL, MULTI-DOSE * .5 mL in 1 PACKET (71288-350-91)

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": "fed2b538-4e01-4e4b-9e92-1750554aba61", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584"], "manufacturer_name": ["Meitheal Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (71288-569-90)  *  1 VIAL, MULTI-DOSE in 1 CARTON (71288-565-03)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  .5 mL in 1 PACKET (71288-350-91)", "package_ndc": "71288-569-90", "marketing_start_date": "20240515"}], "brand_name": "Leuprolide Acetate", "product_id": "71288-569_fed2b538-4e01-4e4b-9e92-1750554aba61", "dosage_form": "KIT", "product_ndc": "71288-569", "generic_name": "Leuprolide Acetate", "labeler_name": "Meitheal Pharmaceuticals Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leuprolide Acetate", "application_number": "ANDA075471", "marketing_category": "ANDA", "marketing_start_date": "20240515", "listing_expiration_date": "20261231"}