Medicine
Miacalcin 200 units/mL injection
Miacalcin 200 units/mL injection is a prescription medicine containing Calcitonin salmon for intramuscular, subcutaneous use, marketed by Mylan Institutional, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.
Key facts
- Active ingredient (INN)
- Calcitonin salmon
- Brand
- Miacalcin
- Strength
- 200 units/mL
- Dosage form
- Injection
- Route
- Intramuscular, subcutaneous
- Packs
- 1 vial
- Marketing authorisation holder
- Mylan Institutional
- Manufacturer
- Mylan Institutional
- Origin register
- US FDA, United States
- Storage
- Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- H05BA01 Calcitonin salmon
- HS code (indicative)
- 3004.39Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 16 September 2016
- Identifiers
- RxCUI 213570, 308866DailyMed set ID 26caf31f-7f7c-48a8-a1ac-35d2ceefda2b, 89cd4f46-b88a-4c10-b25c-47352280dc4e, 753ecc6a-07be-4fc6-9032-cc6ad116a662NDC 72078-039, 67457-675, 72078-038Application NDA017808
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 67457-675-02 | Mylan Institutional | 16 September 2016 |
| 1 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 72078-038-02 | Mylan Institutional | 16 June 2022 |
| 1 vial, multi-dose in 1 carton / 2 mL in 1 vial, multi-dose | 72078-039-02 | Mylan Institutional | 18 July 2022 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 17 April 1978 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Calcitonin salmon 200 units/mL injection.
Other strengths and forms of Calcitonin salmon
Clinical summary
Calcitonin salmon is a calcitonin indicated for conditions, among other approved uses. It is available as injection and nasal spray for intramuscular and subcutaneous use. MedsAcross supplies Calcitonin salmon for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Calcitonin salmonFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Miacalcin prescribing information (Mylan Institutional) · U.S. National Library of Medicine, DailyMed
Need Miacalcin 200 units/mL injection for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.