NDC 66758-035

Granisetron

Granisetron

Granisetron is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc.. The primary component is Granisetron Hydrochloride.

Product ID66758-035_81cd24a3-19ba-4ad8-ba90-da4f0a26f230
NDC66758-035
Product TypeHuman Prescription Drug
Proprietary NameGranisetron
Generic NameGranisetron
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2008-06-30
Marketing End Date2020-05-19
Marketing CategoryANDA / ANDA
Application NumberANDA078835
Labeler NameSandoz Inc.
Substance NameGRANISETRON HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN

Packaging

NDC 66758-035-01

1 VIAL, SINGLE-USE in 1 CARTON (66758-035-01) > 1 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2008-06-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66758-035-01 [66758003501]

Granisetron INJECTION
Marketing CategoryANDA
Application NumberANDA078835
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-06-30
Marketing End Date2020-05-19

Drug Details

Active Ingredients

IngredientStrength
GRANISETRON HYDROCHLORIDE1 mg/mL

OpenFDA Data

SPL SET ID:2eb798cf-f480-408d-8feb-73f4f943e884
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 240912
  • 1734399

    • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]
    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "Granisetron" or generic name "Granisetron"

    NDCBrand NameGeneric Name
    63323-318GranisetronGRANISETRON HYDROCHLORIDE
    63323-319GranisetronGRANISETRON HYDROCHLORIDE
    66758-035GranisetronGranisetron
    66758-036GranisetronGranisetron
    42747-726SANCUSOgranisetron
    47426-101SUSTOLgranisetron
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