Calcitonin Salmon NDC 63323-865

NDC codes

FDA NDC Directory

Product NDC (as listed)63323-865Labeler and product segments. Claims need a package NDC.

Product NDC at billing width63323-0865Add 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
63323-865-02	63323086502	1 VIAL, MULTI-DOSE in 1 CARTON (63323-865-02) / 2 mL in 1 VIAL, MULTI-DOSEMarketed from Dec 5, 2024

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): Calcitonin Salmon
Generic name (nonproprietary): calcitonin salmon
Active ingredients: Calcitonin salmon — 200 [iU]/mL
Dosage form: Injection, Solution
Route: Intramuscular, Subcutaneous
Labeler: Fresenius Kabi USA, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212675
Marketing start: Dec 5, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Calcitonin (Chemical structure)
Identifiers: Product ID 63323-865_e1f330b8-6d38-43d5-ab26-b2a0a790967eSPL ID e1f330b8-6d38-43d5-ab26-b2a0a790967eSPL set ID 2b8c6917-c217-45bf-a0ac-a2fa0f7d497aRxCUI 308866UNII 7SFC6U2VI5UPC 0363323865023
Pharmacologic class: Calcitonin

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

N463323086502 followed by a unit qualifier and the quantity

Package 63323-0865-02. 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 Jul 15, 2026.

Indications (excerpt from the label)

Calcitonin Salmon synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget's disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated ( 1.3 ) Limitations of Use: • Due to the possible association between malignancy and calcitonin-salmon use, the need for continued therapy should be re-evaluated on a periodic basis ( 1.4 , 5.3 ) 1.1 Treatment of Paget's Disease of Bone Calcitonin Salmon injection is indicated for the treatment of symptomatic Paget's di…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)