Camcevi (leuprolide) NDC 69448-014

NDC codes

FDA NDC Directory

Product NDC (as listed)69448-014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69448-0014Add 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
69448-014-63	69448001463	1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGEMarketed from Apr 5, 2022

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): Camcevi
Generic name (nonproprietary): leuprolide
Active ingredients: Leuprolide mesylate — 42 mg/.37g
Dosage form: Injection, Emulsion
Route: Subcutaneous
Labeler: Accord BioPharma, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211488
Marketing start: Apr 5, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Gonadotropin Releasing Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 69448-014_4b1ada65-9911-eacf-e063-6394a90af9d9SPL ID 4b1ada65-9911-eacf-e063-6394a90af9d9SPL set ID d7a8761a-d953-413a-e053-2a95a90a60eeRxCUI 2595044, 2595049UNII 8E3C3C493W
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

N469448001463 followed by a unit qualifier and the quantity

Package 69448-0014-63. 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 Feb 18, 2026.

Indications (excerpt from the label)

CAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 211488

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

FDA NDC Directory listings under NDA 211488
Product	Strength	Form · route	Labeler	Product NDC
Camcevileuprolide	Leuprolide mesylate 42 mg/.37g	Injection, EmulsionSubcutaneous	Accord BioPharma, Inc.	69448-023