NDC 63323-365

Octreotide

Octreotide Acetate

Octreotide is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Octreotide Acetate.

Product ID63323-365_2cde9ad8-ec14-4e68-8207-01a6305561e6
NDC63323-365
Product TypeHuman Prescription Drug
Proprietary NameOctreotide
Generic NameOctreotide Acetate
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2006-03-14
Marketing CategoryANDA / ANDA
Application NumberANDA077457
Labeler NameFresenius Kabi USA, LLC
Substance NameOCTREOTIDE ACETATE
Active Ingredient Strength50 ug/mL
Pharm ClassesSomatostatin Analog [EPC],Somatostatin Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-365-01

10 VIAL, SINGLE-DOSE in 1 TRAY (63323-365-01) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2006-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-365-01 [63323036501]

Octreotide INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-03-14
Marketing End Date2017-06-30

NDC 63323-365-04 [63323036504]

Octreotide INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA077457
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-03-14
Marketing End Date2017-06-30

Drug Details

Active Ingredients

IngredientStrength
OCTREOTIDE ACETATE50 ug/mL

OpenFDA Data

SPL SET ID:f278f0d8-4062-420a-97c3-3a8b88253a08
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312071
  • 312070
  • 312068
  • 312069
  • 314152

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    63323-378OctreotideOctreotide
    63323-376OctreotideOctreotide
    63323-377OctreotideOctreotide
    63323-365OctreotideOctreotide
    63323-379OctreotideOctreotide
    0641-6174Octreotide AcetateOctreotide Acetate
    0641-6175Octreotide AcetateOctreotide Acetate
    0078-0180Sandostatinoctreotide acetate
    0078-0181Sandostatinoctreotide acetate
    0078-0182Sandostatinoctreotide acetate
    0078-0183Sandostatinoctreotide acetate
    0078-0184Sandostatinoctreotide 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
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