leuprolide acetate

Generic: leuprolide acetate

Labeler: vgyaan pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name leuprolide acetate
Generic Name leuprolide acetate
Labeler vgyaan pharmaceuticals llc
Dosage Form KIT
Manufacturer
VGYAAN Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72664-611
Product ID 72664-611_441a43d5-2a8c-2d53-e063-6294a90a385d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213829
Listing Expiration 2026-12-31
Marketing Start 2020-10-25

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72664611
Hyphenated Format 72664-611

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)

Resolved Composition

Strengths
  • 2.8 ml
source: label
Packaging
  • 1 KIT in 1 CARTON (72664-611-28) * 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
source: ndc

Packages (1)

72664-611-28 1 KIT in 1 CARTON (72664-611-28) * 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 
{"spl_id": "441a43d5-2a8c-2d53-e063-6294a90a385d", "openfda": {"rxcui": ["545835", "797544"], "spl_set_id": ["bec9077a-3f04-4887-856d-dde2de24584d"], "manufacturer_name": ["VGYAAN Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (72664-611-28)  *  2.8 mL in 1 VIAL, MULTI-DOSE *  1 mL in 1 PACKET", "package_ndc": "72664-611-28", "marketing_start_date": "20201025"}], "brand_name": "Leuprolide Acetate", "product_id": "72664-611_441a43d5-2a8c-2d53-e063-6294a90a385d", "dosage_form": "KIT", "product_ndc": "72664-611", "generic_name": "Leuprolide Acetate", "labeler_name": "VGYAAN Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Leuprolide Acetate", "application_number": "ANDA213829", "marketing_category": "ANDA", "marketing_start_date": "20201025", "listing_expiration_date": "20261231"}