NDC 0078-0183

Sandostatin

Octreotide Acetate

Sandostatin is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Octreotide Acetate.

Product ID0078-0183_70137f2b-5951-4762-a04a-a002cfac8b87
NDC0078-0183
Product TypeHuman Prescription Drug
Proprietary NameSandostatin
Generic NameOctreotide Acetate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1998-10-21
Marketing CategoryNDA / NDA
Application NumberNDA019667
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameOCTREOTIDE ACETATE
Active Ingredient Strength200 ug/mL
Pharm ClassesSomatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0078-0183-25

1 VIAL, MULTI-DOSE in 1 BOX (0078-0183-25) > 5 mL in 1 VIAL, MULTI-DOSE
Marketing Start Date1998-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0183-25 [00078018325]

Sandostatin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019667
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1988-10-21
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
OCTREOTIDE ACETATE200 ug/mL

OpenFDA Data

SPL SET ID:4e2c9856-1836-49f0-9472-4dbeeb408f39
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312071
  • 312070
  • 207201
  • 207200
  • 312068
  • 312069
  • 207199
  • 207198
  • 207194
  • 314152

    • Pharmacological Class

    • Somatostatin Analog [EPC]
    • Somatostatin Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Sandostatin" or generic name "Octreotide Acetate"

    NDCBrand NameGeneric Name
    0078-0180Sandostatinoctreotide acetate
    0078-0181Sandostatinoctreotide acetate
    0078-0182Sandostatinoctreotide acetate
    0078-0183Sandostatinoctreotide acetate
    0078-0184Sandostatinoctreotide acetate
    0641-6174Octreotide AcetateOctreotide Acetate
    0641-6175Octreotide AcetateOctreotide Acetate
    0078-0647Sandostatin LAR Depotoctreotide acetate
    0078-0648Sandostatin LAR Depotoctreotide acetate
    0078-0811Sandostatin LAR Depotoctreotide acetate
    0078-0818Sandostatin LAR Depotoctreotide acetate
    0078-0825Sandostatin LAR Depotoctreotide acetate

    Trademark Results [Sandostatin]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SANDOSTATIN
    SANDOSTATIN
    73572578 1412956 Live/Registered
    SANDOZ PHARMACEUTICALS CORPORATION
    1985-12-09
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