NDC 0078-0181

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 ID0078-0181_5b689d42-d065-4d77-be63-0d30a07deb89
NDC0078-0181
Product TypeHuman Prescription Drug
Proprietary NameSandostatin
Generic NameOctreotide Acetate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date1988-10-21
Marketing CategoryNDA / NDA
Application NumberNDA019667
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameOCTREOTIDE ACETATE
Active Ingredient Strength100 ug/mL
Pharm ClassesSomatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0181-01

10 AMPULE in 1 PACKAGE (0078-0181-01) > 1 mL in 1 AMPULE (0078-0181-61)
Marketing Start Date1988-10-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0181-01 [00078018101]

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

NDC 0078-0181-61 [00078018161]

Sandostatin INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA019667
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-08-13

Drug Details

Active Ingredients

IngredientStrength
OCTREOTIDE ACETATE100 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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