Quick answers
- What is Calcitonin salmon used for?
- The FDA-approved label (Miacalcin, Mylan Institutional LLC, September 15, 2024) says: “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 • Treatment of hypercalcemia • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Calcitonin salmon have a boxed warning?
- No. None of the 14 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Calcitonin salmon?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Calcitonin salmon been recalled?
- FDA enforcement reports list 2 recalls of products of this medicine; the newest started April 26, 2023 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Calcitonin salmon?
- 11 companies list prescription products of Calcitonin salmon in the FDA NDC Directory, including Mylan Institutional LLC, Par Health USA, LLC and Zydus Lifesciences Limited.
What Calcitonin salmon is used for
Quoted from the “Indications and Usage” section of the FDA-approved 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 • Treatment of hypercalcemia • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable. Fracture reduction efficacy has not been demonstrated Limitations of Use …
— FDA label: Miacalcin, Mylan Institutional LLC, effective September 15, 2024. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, solution · Spray, metered |
|---|---|
| Route | Intramuscular · Subcutaneous · Nasal |
| Prescription products | 14 in the FDA NDC Directory |
| Brand names | Miacalcin |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| calcitonin salmon 200 units spray, metered | Generic | $13.51 per mL |
| calcitonin salmon 200 units/0.09 mL spray, metered | Generic | $13.51 per mL |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Mylan Institutional LLC3 products
- Par Health USA, LLC2 products
- Zydus Lifesciences Limited1 product
- Cipla USA Inc.1 product
- Hikma Pharmaceuticals USA Inc.1 product
- Apotex Corp.1 product
- Sagent Pharmaceuticals1 product
- Fresenius Kabi USA, LLC1 product
- Dr. Reddy's Laboratories Inc.1 product
- Amneal Pharmaceuticals LLC1 product
- Zydus Pharmaceuticals USA Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA017808 MIACALCIN | Mylan Ireland Ltd | July 3, 1986 | 27, latest September 11, 2017 2017: Labeling · 2015: Labeling · 2014: Labeling |
Generic approvals (10)
- ANDA076396Apotex Inc · November 17, 2008
- ANDA076979Ph Health · June 8, 2009
- ANDA212416Custopharm Inc · May 14, 2021
- ANDA209358Ph Health · November 10, 2021
- ANDA215715DR Reddys · April 11, 2024
- ANDA213766Cipla · September 20, 2024
- ANDA212675Fresenius Kabi USA · December 5, 2024
- ANDA219196Sagent · July 9, 2025
- ANDA216294Amneal · September 26, 2025
- ANDA215864Zydus Pharms · March 4, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
April 26, 2023 · Class II · Completed · D-0568-2023
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC — Apotex Corp.
-
March 2, 2023 · Class II · Terminated · D-0475-2023
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11. — Endo Pharmaceuticals, Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 213570, 308866, 313919 |
|---|---|
| SPL set ID of the quoted label | 26caf31f-7f7c-48a8-a1ac-35d2ceefda2b |
| FDA labels (SPL) | 14 |
| FDA applications | NDA017808, 10 ANDA |
| Active ingredients (FDA) | CALCITONIN SALMON |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Miacalcin, Mylan Institutional LLC, effective September 15, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →