Miacalcin
These highlights do not include all the information needed to use MIACALCIN INJECTION safely and effectively. See full prescribing information for MIACALCIN INJECTION. MIACALCIN (calcitonin salmon) injection, synthetic, for subcutaneous or intramuscular useInitial U.S. Approval: 1975
Approved
Approval ID
26caf31f-7f7c-48a8-a1ac-35d2ceefda2b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
calcitonin salmon
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72078-039
Application NumberNDA017808
Product Classification
M
Marketing Category
C73594
G
Generic Name
calcitonin salmon
Product Specifications
Route of AdministrationINTRAMUSCULAR, SUBCUTANEOUS
Effective DateAugust 15, 2021
FDA Product Classification
INGREDIENTS (6)
CALCITONIN SALMONActive
Quantity: 200 [USP'U] in 1 mL
Code: 7SFC6U2VI5
Classification: ACTIB
PHENOLInactive
Quantity: 5 mg in 1 mL
Code: 339NCG44TV
Classification: IACT
ACETIC ACIDInactive
Quantity: 2.25 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 7.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT