Prescription medicine
Calcitonin salmon Brand names: Miacalcin; first approved as Calcimar
Calcitonin salmon (Miacalcin) is a prescription medicine with an FDA approval on record since 1978. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $13.10 per mL (Calcitonin-salmon 200 unit spr) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the calcitonin salmon FDA label on DailyMed (effective September 15, 2024, Mylan Institutional LLC); the NDA 17769 record on Drugs@FDA; every calcitonin salmon label on DailyMed.
Highlights of the record
FDA label of September 15, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageMiacalcin 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.
Forms and strengths
- 0.09ml
- 2ml
Injection (solution); spray (metered).
On the market
- Earliest approval on file
- April 17, 1978 Calcimar, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 10 first November 17, 2008; 10 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $13.10 per mL Calcitonin-salmon 200 unit spr
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2023 0 Class I among all firms' recalls; latest April 26, 2023
- FAERS reports
- 3,109 through July 30, 2026
What is calcitonin salmon used for?
From the label: indications and usageMiacalcin 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. […]
Conditions named in the indications of calcitonin salmon's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Calcitonin.
Source: FDA drug label (Miacalcin), Mylan Institutional LLC, effective September 15, 2024 (SPL set 26caf31f-7f7c-48a8-a1ac-35d2ceefda2b), via openFDA; the full label on DailyMed
Is there a generic for calcitonin salmon (Miacalcin)?
The FDA approved the first generic calcitonin salmon on November 17, 2008. 10 generic applications are approved; 10 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists calcitonin salmon from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1978 earliest approval on file
- 2008 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for calcitonin salmon (Miacalcin)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $13.10 per mL (Calcitonin-salmon 200 unit spr), up 13% from $11.64 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Calcitonin-salmon 200 unit spr (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Calcitonin-salmon 200 unit spr | Generic | $13.10 per mL | n/a | +13% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has calcitonin salmon been recalled?
The FDA's Enforcement Report lists 2 recalls naming calcitonin salmon since 2023: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 26, 2023 | Class II | Apotex Corp. | Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. |
| March 2, 2023 | Class II | Endo Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the calcitonin salmon label say about other medicines?
The calcitonin salmon label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Lithium | drug interactions | Concomitant use of calcitonin salmon and lithium may lead to a reduction in plasma lithium concentrations due to increased urinary clearance of lithium. |
Source: FDA drug label (Miacalcin), Mylan Institutional LLC, effective September 15, 2024 (SPL set 26caf31f-7f7c-48a8-a1ac-35d2ceefda2b), via openFDA; the full label on DailyMed
What do FAERS reports show for calcitonin salmon?
The FDA Adverse Event Reporting System holds 3,109 reports that list calcitonin salmon among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 278 are coded as a death and 997 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
How does calcitonin salmon compare with medicines for the same use?
1 side-by-side page set calcitonin salmon beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Calcitonin salmon side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other