NDC 67457-675

Miacalcin

Calcitonin Salmon

Miacalcin is a Intramuscular; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Calcitonin Salmon.

Product ID67457-675_1e8f8156-be45-4916-9b9f-c4902e888596
NDC67457-675
Product TypeHuman Prescription Drug
Proprietary NameMiacalcin
Generic NameCalcitonin Salmon
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; SUBCUTANEOUS
Marketing Start Date2016-09-16
Marketing CategoryNDA / NDA
Application NumberNDA017808
Labeler NameMylan Institutional LLC
Substance NameCALCITONIN SALMON
Active Ingredient Strength200 [USP'U]/mL
Pharm ClassesCalcitonin [CS],Calcitonin [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-675-02

1 VIAL, MULTI-DOSE in 1 CARTON (67457-675-02) > 2 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date2016-09-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-675-02 [67457067502]

Miacalcin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA017808
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2016-09-16

Drug Details

Active Ingredients

IngredientStrength
CALCITONIN SALMON200 [USP'U]/mL

OpenFDA Data

SPL SET ID:89cd4f46-b88a-4c10-b25c-47352280dc4e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 213570
  • 308866

    • Pharmacological Class

    • Calcitonin [CS]
    • Calcitonin [EPC]
    • Calcitonin [CS]
    • Calcitonin [EPC]

    NDC Crossover Matching brand name "Miacalcin" or generic name "Calcitonin Salmon"

    NDCBrand NameGeneric Name
    67457-675Miacalcincalcitonin salmon
    72078-038Miacalcincalcitonin salmon
    72078-039Miacalcincalcitonin salmon
    0781-6320calcitonin salmoncalcitonin salmon
    24201-400Calcitonin Salmoncalcitonin salmon
    42023-205Calcitonin SalmonCalcitonin Salmon
    49884-161CALCITONIN SALMONCALCITONIN SALMON
    60505-0823Calcitonin SalmonCalcitonin Salmon
    63629-2152CALCITONIN SALMONCALCITONIN SALMON
    0245-0008Forticalcalcitonin salmon

    Trademark Results [Miacalcin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MIACALCIN
    MIACALCIN
    74255027 1726984 Live/Registered
    NOVARTIS AG
    1992-03-13
    MIACALCIN
    MIACALCIN
    73495876 1362853 Dead/Cancelled
    SANDOZ, INC.,
    1984-08-21
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