leuprolide acetate

Generic: leuprolide acetate

Labeler: northstar rxllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler northstar rxllc
Dosage Form KIT
Routes
SUBCUTANEOUS
Manufacturer
NorthStar RxLLC

Identifiers & Regulatory

Product NDC 72603-344
Product ID 72603-344_384e8664-07e6-3817-e063-6294a90a8385
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213829
Listing Expiration 2026-12-31
Marketing Start 2024-03-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72603344
Hyphenated Format 72603-344

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 ANDA213829 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET
source: ndc

Packages (1)

72603-344-01 1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01) / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 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": "384e8664-07e6-3817-e063-6294a90a8385", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["0cf31b40-816b-d055-e063-6294a90af5d0"], "manufacturer_name": ["NorthStar RxLLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72603-344-01)  *  1 VIAL, MULTI-DOSE in 1 CARTON (72603-201-01)  / 2.8 mL in 1 VIAL, MULTI-DOSE *  28 PACKET in 1 CARTON / 1 mL in 1 PACKET", "package_ndc": "72603-344-01", "marketing_start_date": "20240301"}], "brand_name": "Leuprolide Acetate", "product_id": "72603-344_384e8664-07e6-3817-e063-6294a90a8385", "dosage_form": "KIT", "product_ndc": "72603-344", "generic_name": "Leuprolide Acetate", "labeler_name": "NorthStar RxLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leuprolide Acetate", "application_number": "ANDA213829", "marketing_category": "ANDA", "marketing_start_date": "20240301", "listing_expiration_date": "20261231"}