Prescription drug · NDA
Miacalcin (Calcitonin salmon) NDC 72078-038
Calcitonin salmon 200 [USP'U]/mL · Injection, Solution · Intramuscular, Subcutaneous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72078-038-02 | 7207800380272078003802 | 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 LLCNDC labeler code 72078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017808
- Marketing start
- Listing expires
- 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.
- NDC on a medical claim
N472078003802followed by a unit qualifier and the quantityPackage 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 .
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.
About NDC 72078-038
- What is NDC 72078-038?
- 72078-038 is the product NDC for Miacalcin (calcitonin salmon), Calcitonin salmon 200 [USP'U]/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Miacalcin (Calcitonin salmon).
- What is the active ingredient?
- Calcitonin salmon.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 72078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Miacalcin?
- 2 other product NDCs are listed under this name. See all Miacalcin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Miacalcin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Miacalcincalcitonin salmon | Calcitonin salmon 200 [USP'U]/mL | Injection, SolutionIntramuscular, Subcutaneous | Mylan Institutional LLC | 72078-039 | 72078-0039-02 |
| Miacalcincalcitonin salmon | Calcitonin salmon 200 [USP'U]/mL | Injection, SolutionIntramuscular, Subcutaneous | Mylan Institutional LLC | 67457-675 | 67457-0675-02 |
Other NDCs under NDA 017808
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Miacalcincalcitonin salmon | Calcitonin salmon 200 [USP'U]/mL | Injection, SolutionIntramuscular, Subcutaneous | Mylan Institutional LLC | 67457-675 |
| Miacalcincalcitonin salmon | Calcitonin salmon 200 [USP'U]/mL | Injection, SolutionIntramuscular, Subcutaneous | Mylan Institutional LLC | 72078-039 |