Fensolvi (leuprolide acetate) NDC 62935-163

NDC codes

FDA NDC Directory

Product NDC (as listed)62935-163Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62935-0163Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
62935-163-60	62935016360	1 SYRINGE in 1 CARTON (62935-163-60) / .375 mL in 1 SYRINGEMarketed from Mar 6, 2023

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): Fensolvi
Generic name (nonproprietary): leuprolide acetate
Active ingredients: Leuprolide acetate — 45 mg/.375mL
Dosage form: Injection, Suspension, Extended release
Route: Subcutaneous
Labeler: TOLMAR Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213150
Marketing start: Mar 6, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 62935-163_6ad49800-db23-42bb-8543-1bbb6a9c96f2SPL ID 6ad49800-db23-42bb-8543-1bbb6a9c96f2SPL set ID 2c311700-edf4-4f2a-a468-9875489a6cc7RxCUI 752884, 2371773UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N462935016360 followed by a unit qualifier and the quantity

Package 62935-0163-60. 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 Sep 25, 2025.

Indications (excerpt from the label)

FENSOLVI ® is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP). FENSOLVI is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 213150

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 213150
Product	Strength	Form · route	Labeler	Product NDC
Fensolvileuprolide acetate	—	Kit	TOLMAR Inc.	62935-153