Miacalcin (calcitonin salmon) NDC 72078-038

NDC codes

FDA NDC Directory

Product NDC (as listed)72078-038Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72078-0038Add 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
72078-038-02	72078003802	1 VIAL, MULTI-DOSE in 1 CARTON (72078-038-02) / 2 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 16, 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): Miacalcin
Generic name (nonproprietary): calcitonin salmon
Active ingredients: Calcitonin salmon — 200 [USP'U]/mL
Dosage form: Injection, Solution
Route: Intramuscular, Subcutaneous
Labeler: Mylan Institutional LLC
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 017808
Marketing start: Jun 16, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Calcitonin (Chemical structure)
Identifiers: Product ID 72078-038_dcebf7f6-2228-4c7a-a81b-ea0507bcb367SPL ID dcebf7f6-2228-4c7a-a81b-ea0507bcb367SPL set ID 753ecc6a-07be-4fc6-9032-cc6ad116a662RxCUI 213570, 308866UNII 7SFC6U2VI5UPC 0372078038026
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

N472078003802 followed by a unit qualifier and the quantity

Package 72078-0038-02. 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 Sep 15, 2024.

Indications (excerpt from the label)

Miacalcin 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 Miacalcin injection is indicated for the treatment of symptomatic Paget’s disease of bone in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 017808

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

FDA NDC Directory listings under NDA 017808
Product	Strength	Form · route	Labeler	Product NDC
Miacalcincalcitonin salmon	Calcitonin salmon 200 [USP'U]/mL	Injection, SolutionIntramuscular, Subcutaneous	Mylan Institutional LLC	72078-039
Miacalcincalcitonin salmon	Calcitonin salmon 200 [USP'U]/mL	Injection, SolutionIntramuscular, Subcutaneous	Mylan Institutional LLC	67457-675