NDC 76135-005

Octreotide Acetate

Octreotide Acetate

Octreotide Acetate is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Usv North America Inc.. The primary component is Octreotide Acetate.

Product ID76135-005_a08b3cbe-bfce-4e7e-9f07-981410c9650f
NDC76135-005
Product TypeHuman Prescription Drug
Proprietary NameOctreotide Acetate
Generic NameOctreotide Acetate
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-01-01
Marketing CategoryANDA / ANDA
Application NumberANDA203765
Labeler NameUSV North America Inc.
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 76135-005-01

5 mL in 1 VIAL, GLASS (76135-005-01)
Marketing Start Date2019-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 76135-005-01 [76135000501]

Octreotide Acetate INJECTION
Marketing CategoryANDA
Application NumberANDA203765
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
OCTREOTIDE ACETATE200 ug/mL

OpenFDA Data

SPL SET ID:6b55eedd-4160-49f8-966b-55b0e60a4b06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312071
  • 314152
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0641-6174Octreotide AcetateOctreotide Acetate
    0641-6175Octreotide AcetateOctreotide Acetate
    76135-009OCTREOTIDE ACETATEOCTREOTIDE ACETATE
    76135-005Octreotide AcetateOctreotide Acetate
    76135-006Octreotide AcetateOctreotide Acetate
    76135-010OCTREOTIDE ACETATEOCTREOTIDE ACETATE
    76135-011OCTREOTIDE ACETATEOCTREOTIDE ACETATE
    0641-6177Octreotide AcetateOctreotide Acetate
    0641-6178Octreotide AcetateOctreotide Acetate
    0641-6176Octreotide AcetateOctreotide Acetate
    0703-3301Octreotide AcetateOctreotide Acetate
    0703-3311Octreotide AcetateOctreotide Acetate
    0703-3321Octreotide AcetateOctreotide Acetate
    0703-3343Octreotide AcetateOctreotide Acetate
    0703-3333Octreotide AcetateOctreotide Acetate
    0781-3168Octreotide AcetateOctreotide Acetate
    0781-3167Octreotide AcetateOctreotide Acetate
    0781-3164Octreotide AcetateOctreotide Acetate
    0781-3166Octreotide AcetateOctreotide Acetate
    0781-3165Octreotide AcetateOctreotide Acetate
    25021-452Octreotide AcetateOctreotide Acetate
    25021-451Octreotide AcetateOctreotide Acetate
    25021-454Octreotide AcetateOctreotide Acetate
    25021-455Octreotide AcetateOctreotide Acetate
    25021-453Octreotide AcetateOctreotide Acetate
    55648-633Octreotide acetateOctreotide acetate
    55648-632Octreotide acetateOctreotide acetate
    55648-636Octreotide acetateOctreotide acetate
    55648-635Octreotide acetateOctreotide acetate
    55648-634Octreotide acetateOctreotide acetate
    64679-633Octreotide acetateOctreotide acetate
    64679-636Octreotide acetateOctreotide acetate
    64679-632Octreotide acetateOctreotide acetate
    64679-634Octreotide acetateOctreotide acetate
    64679-635Octreotide acetateOctreotide acetate
    67457-246Octreotide AcetateOctreotide Acetate
    67457-245Octreotide AcetateOctreotide Acetate
    67457-239Octreotide 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.