vabrinty

Generic: leuprolide acetate

Labeler: uronova pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name vabrinty
Generic Name leuprolide acetate
Labeler uronova pharmaceuticals, inc.
Dosage Form INJECTION, SUSPENSION, EXTENDED RELEASE
Routes
SUBCUTANEOUS
Active Ingredients

leuprolide acetate 7.5 mg/.25mL

Manufacturer
URONOVA PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 85043-075
Product ID 85043-075_b8da8614-75a8-453c-be31-0568da16a3b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021343
Listing Expiration 2027-12-31
Marketing Start 2025-12-15

Pharmacologic Class

Classes
gonadotropin releasing hormone receptor agonist [epc] gonadotropin releasing hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85043075
Hyphenated Format 85043-075

Supplemental Identifiers

RxCUI
752884 752889 752894 752899 2720345 2720348 2723399 2728996
UNII
37JNS02E7V

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 vabrinty (source: ndc)
Generic Name leuprolide acetate (source: ndc)
Application Number NDA021343 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/.25mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (85043-075-05) / .25 mL in 1 SYRINGE
  • 1 SYRINGE in 1 CARTON (85043-075-50) / .25 mL in 1 SYRINGE
source: ndc

Packages (2)

85043-075-05 1 SYRINGE in 1 CARTON (85043-075-05) / .25 mL in 1 SYRINGE 85043-075-50 1 SYRINGE in 1 CARTON (85043-075-50) / .25 mL in 1 SYRINGE

Ingredients (1)

leuprolide acetate (7.5 mg/.25mL)

Linked Drug Pages (1)

Vabrinty ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "b8da8614-75a8-453c-be31-0568da16a3b9", "openfda": {"unii": ["37JNS02E7V"], "rxcui": ["752884", "752889", "752894", "752899", "2720345", "2720348", "2723399", "2728996"], "spl_set_id": ["008776cc-83f1-4f8c-819b-6471425da15f"], "manufacturer_name": ["URONOVA PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (85043-075-05)  / .25 mL in 1 SYRINGE", "package_ndc": "85043-075-05", "marketing_start_date": "20251215"}, {"sample": true, "description": "1 SYRINGE in 1 CARTON (85043-075-50)  / .25 mL in 1 SYRINGE", "package_ndc": "85043-075-50", "marketing_start_date": "20260202"}], "brand_name": "Vabrinty", "product_id": "85043-075_b8da8614-75a8-453c-be31-0568da16a3b9", "dosage_form": "INJECTION, SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Gonadotropin Releasing Hormone Receptor Agonist [EPC]", "Gonadotropin Releasing Hormone Receptor Agonists [MoA]"], "product_ndc": "85043-075", "generic_name": "Leuprolide acetate", "labeler_name": "URONOVA PHARMACEUTICALS, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vabrinty", "active_ingredients": [{"name": "LEUPROLIDE ACETATE", "strength": "7.5 mg/.25mL"}], "application_number": "NDA021343", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20251215", "listing_expiration_date": "20271231"}