leuprolide acetate

Generic: leuprolide acetate

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

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler ubi pharma inc.
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
UBI Pharma Inc.

Identifiers & Regulatory

Product NDC 72843-591
Product ID 72843-591_468261fd-e2c6-273c-e063-6294a90a7300
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217957
Listing Expiration 2026-12-31
Marketing Start 2024-10-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72843591
Hyphenated Format 72843-591

Supplemental Identifiers

RxCUI
545835 797544
UPC
0072843590017

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
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
source: ndc

Packages (1)

72843-591-99 1 KIT in 1 CARTON (72843-591-99) * 1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01) / 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 
{"route": ["SUBCUTANEOUS"], "spl_id": "468261fd-e2c6-273c-e063-6294a90a7300", "openfda": {"upc": ["0072843590017"], "rxcui": ["545835", "797544"], "spl_set_id": ["cd46628f-055f-4da9-8c38-fa69af34eb4d"], "manufacturer_name": ["UBI Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72843-591-99)  *  1 VIAL, MULTI-DOSE in 1 CARTON (72843-590-01)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET", "package_ndc": "72843-591-99", "marketing_start_date": "20241025"}], "brand_name": "leuprolide acetate", "product_id": "72843-591_468261fd-e2c6-273c-e063-6294a90a7300", "dosage_form": "KIT", "product_ndc": "72843-591", "generic_name": "leuprolide acetate", "labeler_name": "UBI Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "leuprolide acetate", "application_number": "ANDA217957", "marketing_category": "ANDA", "marketing_start_date": "20241025", "listing_expiration_date": "20261231"}