leuprolide acetate

Generic: leuprolide acetate

Labeler: avenacy inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler avenacy inc.
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
Avenacy Inc.

Identifiers & Regulatory

Product NDC 83634-454
Product ID 83634-454_92eaabb9-7dde-4153-9794-fa0f0b72b05f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217957
Listing Expiration 2026-12-31
Marketing Start 2025-03-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83634454
Hyphenated Format 83634-454

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 ANDA217957 (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 (83634-454-61) * 1 mL in 1 PACKET (83634-453-01) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03)
source: ndc

Packages (1)

83634-454-61 1 KIT in 1 CARTON (83634-454-61) * 1 mL in 1 PACKET (83634-453-01) * 2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03)

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": "92eaabb9-7dde-4153-9794-fa0f0b72b05f", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["15003c37-6e91-4c79-a85c-3d03343b53f9"], "manufacturer_name": ["Avenacy Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (83634-454-61)  *  1 mL in 1 PACKET (83634-453-01)  *  2.8 mL in 1 VIAL, MULTI-DOSE (83634-452-03)", "package_ndc": "83634-454-61", "marketing_start_date": "20250315"}], "brand_name": "Leuprolide Acetate", "product_id": "83634-454_92eaabb9-7dde-4153-9794-fa0f0b72b05f", "dosage_form": "KIT", "product_ndc": "83634-454", "generic_name": "leuprolide acetate", "labeler_name": "Avenacy Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leuprolide Acetate", "application_number": "ANDA217957", "marketing_category": "ANDA", "marketing_start_date": "20250315", "listing_expiration_date": "20261231"}