NDC 47426-101

SUSTOL

Granisetron

SUSTOL is a Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Heron Therapeutics. The primary component is Granisetron.

• Product ID: 47426-101_604ba67d-7f4e-4f02-956d-221f0a7aa21e
• NDC: 47426-101
• Product Type: Human Prescription Drug
• Proprietary Name: SUSTOL
• Generic Name: Granisetron
• Dosage Form: Injection
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2016-08-09
• Marketing Category: NDA / NDA
• Application Number: NDA022445
• Labeler Name: Heron Therapeutics
• Substance Name: GRANISETRON
• Active Ingredient Strength: 10 mg/.4mL
• Pharm Classes: Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 47426-101-06

6 KIT in 1 CARTON (47426-101-06) > 1 SYRINGE, GLASS in 1 KIT > .4 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2016-08-09
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 47426-101-06 [47426010106]

SUSTOL INJECTION

• Marketing Category: NDA
• Application Number: NDA022445
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-08-09

NDC 47426-101-01 [47426010101]

SUSTOL INJECTION

• Marketing Category: NDA
• Application Number: NDA022445
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-08-09
• Marketing End Date: 2016-08-09

Drug Details

Active Ingredients

Ingredient	Strength
GRANISETRON	10 mg/.4mL

OpenFDA Data

• SPL SET ID: f7c7ffdd-8270-4030-bc1e-a1cb28a6de56
• Manufacturer:
  • Heron Therapeutics
• UNII:
  • WZG3J2MCOL
• RxNorm Concept Unique ID - RxCUI:
  • 1810489
  • 1810484

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 "SUSTOL" or generic name "Granisetron"

NDC	Brand Name	Generic Name
47426-101	SUSTOL	granisetron
66758-035	Granisetron	Granisetron
66758-036	Granisetron	Granisetron
42747-726	SANCUSO	granisetron