leuprolide acetate

Generic: leuprolide acetate

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler eugia us llc
Dosage Form KIT
Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-478
Product ID 55150-478_35f9ff51-c430-45b4-b601-ba27a1c94ff2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212963
Listing Expiration 2026-12-31
Marketing Start 2022-06-06

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150478
Hyphenated Format 55150-478

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 ANDA212963 (source: ndc)

Resolved Composition

Strengths
  • 2.8 ml
  • 14 mg/2.8 ml
  • 1 mg/0.2 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (60913-006-01)
source: ndc

Packages (1)

55150-478-01 1 KIT in 1 CARTON (55150-478-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET (60913-006-01)

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": "35f9ff51-c430-45b4-b601-ba27a1c94ff2", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["49a1d0c1-304c-46f2-a780-bd940ae1ced0"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (55150-478-01)  *  1 VIAL, MULTI-DOSE in 1 CARTON (55150-338-01)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET (60913-006-01)", "package_ndc": "55150-478-01", "marketing_start_date": "20220606"}], "brand_name": "LEUPROLIDE ACETATE", "product_id": "55150-478_35f9ff51-c430-45b4-b601-ba27a1c94ff2", "dosage_form": "KIT", "product_ndc": "55150-478", "generic_name": "LEUPROLIDE ACETATE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LEUPROLIDE ACETATE", "application_number": "ANDA212963", "marketing_category": "ANDA", "marketing_start_date": "20220606", "listing_expiration_date": "20261231"}