NDC 63323-319

Granisetron

Granisetron Hydrochloride

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

• Product ID: 63323-319_18ed9a54-6933-4a2a-b881-a6d866285b05
• NDC: 63323-319
• Product Type: Human Prescription Drug
• Proprietary Name: Granisetron
• Generic Name: Granisetron Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2009-11-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078090
• Labeler Name: Fresenius Kabi USA, LLC
• Substance Name: GRANISETRON HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63323-319-04

1 VIAL in 1 BOX (63323-319-04) > 4 mL in 1 VIAL

• Marketing Start Date: 2009-11-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63323-319-04 [63323031904]

Granisetron INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078090
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2009-11-20

Drug Details

Active Ingredients

Ingredient	Strength
GRANISETRON HYDROCHLORIDE	1 mg/mL

OpenFDA Data

• SPL SET ID: dddc8714-383f-4bc5-a468-ae89dbc802b4
• Manufacturer:
  • Fresenius Kabi USA, LLC
• UNII:
  • 318F6L70J8
• RxNorm Concept Unique ID - RxCUI:
  • 543218
  • 240912
  • 1734399

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
63323-318	Granisetron	Granisetron
63323-319	Granisetron	Granisetron
66758-035	Granisetron	Granisetron
66758-036	Granisetron	Granisetron
0054-0143	Granisetron Hydrochloride	Granisetron Hydrochloride
0093-7485	Granisetron Hydrochloride	Granisetron Hydrochloride
0143-9744	Granisetron Hydrochloride	Granisetron Hydrochloride
0143-9745	Granisetron Hydrochloride	Granisetron Hydrochloride
16714-221	Granisetron Hydrochloride	Granisetron Hydrochloride
17478-546	Granisetron Hydrochloride	Granisetron Hydrochloride
17478-547	Granisetron Hydrochloride	Granisetron Hydrochloride
25021-779	granisetron hydrochloride	granisetron hydrochloride
25021-781	granisetron hydrochloride	granisetron hydrochloride
42043-390	Granisetron Hydrochloride	Granisetron Hydrochloride
51672-4138	Granisetron Hydrochloride	Granisetron Hydrochloride
51991-735	Granisetron Hydrochloride	Granisetron Hydrochloride
55150-175	Granisetron Hydrochloride	Granisetron Hydrochloride
55150-176	Granisetron Hydrochloride	Granisetron Hydrochloride
55648-661	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE
55648-662	GRANISETRON HYDROCHLORIDE	GRANISETRON HYDROCHLORIDE
63126-331	Granisetron Hydrochloride	Granisetron Hydrochloride
42747-726	SANCUSO	granisetron
47426-101	SUSTOL	granisetron