Prescription drug · NDA AUTHORIZED GENERIC
Vabrinty (leuprolide acetate) NDC 85043-075
Leuprolide acetate 7.5 mg/.25mL · Injection, Suspension, Extended release · Subcutaneous · URONOVA PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85043-075-05 | 85043007505 | 1 SYRINGE in 1 CARTON (85043-075-05) / .25 mL in 1 SYRINGEMarketed from Dec 15, 2025 | |
| 85043-075-50 | 85043007550 | 1 SYRINGE in 1 CARTON (85043-075-50) / .25 mL in 1 SYRINGEMarketed from Feb 2, 2026 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Vabrinty
- Generic name (nonproprietary)
- leuprolide acetate
- Active ingredients
- Leuprolide acetate — 7.5 mg/.25mL
- Dosage form
- Injection, Suspension, Extended release
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 021343
- Marketing start
- Listing expires
- Other FDA classes
- Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 85043-075_27e114f0-8c42-47c3-bcb8-0da93eb9a5fbSPL ID 27e114f0-8c42-47c3-bcb8-0da93eb9a5fbSPL set ID 008776cc-83f1-4f8c-819b-6471425da15fRxCUI 752889, 752894, 752899, 2720345, 2720348, 2723399, 2728996, 752884UNII 37JNS02E7V
- Pharmacologic class
- Gonadotropin Releasing Hormone Receptor Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N485043007505followed by a unit qualifier and the quantityPackage 85043-0075-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021343
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.