NDC 0245-0008

Fortical

Calcitonin Salmon

Fortical is a Nasal Spray, Metered in the Human Prescription Drug category. It is labeled and distributed by Upsher-smith Laboratories, Inc.. The primary component is Calcitonin Salmon.

Product ID0245-0008_2905a738-af8b-4baa-9c2f-67769897220c
NDC0245-0008
Product TypeHuman Prescription Drug
Proprietary NameFortical
Generic NameCalcitonin Salmon
Dosage FormSpray, Metered
Route of AdministrationNASAL
Marketing Start Date2005-08-12
Marketing CategoryNDA / NDA
Application NumberNDA021406
Labeler NameUpsher-Smith Laboratories, Inc.
Substance NameCALCITONIN SALMON
Active Ingredient Strength2200 [iU]/mL
Pharm ClassesCalcitonin [CS],Calcitonin [EPC]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0245-0008-35

1 BOTTLE, SPRAY in 1 CARTON (0245-0008-35) > 3.7 mL in 1 BOTTLE, SPRAY
Marketing Start Date2005-08-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0245-0008-35 [00245000835]

Fortical SPRAY, METERED
Marketing CategoryNDA
Application NumberNDA021406
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-08-12
Marketing End Date2018-12-04

Drug Details

Active Ingredients

IngredientStrength
CALCITONIN SALMON2200 [iU]/mL

OpenFDA Data

SPL SET ID:e273664a-3f6d-4ed4-9495-3fe8338e7895
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 688596
  • 313919

    • Pharmacological Class

    • Calcitonin [CS]
    • Calcitonin [EPC]

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

    NDCBrand NameGeneric Name
    0245-0008Forticalcalcitonin 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
    67457-675Miacalcincalcitonin salmon
    72078-038Miacalcincalcitonin salmon
    72078-039Miacalcincalcitonin salmon

    Trademark Results [Fortical]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FORTICAL
    FORTICAL
    87020351 5086705 Live/Registered
    Purple Cow Organics, LLC
    2016-04-30
    FORTICAL
    FORTICAL
    77177956 not registered Dead/Abandoned
    Chemische Fabrik Budenheim KG
    2007-05-10
    FORTICAL
    FORTICAL
    74608739 2457466 Live/Registered
    ENTERIS BIOPHARMA, INC.
    1994-12-08
    FORTICAL
    FORTICAL
    74485072 1917114 Live/Registered
    ENTERIS BIOPHARMA, INC.
    1994-02-01
    FORTICAL
    FORTICAL
    73548130 1410077 Dead/Cancelled
    N.V. NUTRICIA
    1985-07-15
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