sustol

Generic: granisetron

Labeler: heron therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sustol
Generic Name granisetron
Labeler heron therapeutics, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

granisetron 10 mg/.4mL

Manufacturer
Heron Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 47426-101
Product ID 47426-101_d4d4e836-ebba-4666-b6da-9d5a846dfcf8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022445
Listing Expiration 2027-12-31
Marketing Start 2016-08-09

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47426101
Hyphenated Format 47426-101

Supplemental Identifiers

RxCUI
1810484 1810489
UNII
WZG3J2MCOL
NUI
N0000175817 N0000175818

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sustol (source: ndc)
Generic Name granisetron (source: ndc)
Application Number NDA022445 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/.4mL
source: ndc
Packaging
  • 6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

granisetron (10 mg/.4mL)

Linked Drug Pages (1)

SUSTOL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "d4d4e836-ebba-4666-b6da-9d5a846dfcf8", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["WZG3J2MCOL"], "rxcui": ["1810484", "1810489"], "spl_set_id": ["f7c7ffdd-8270-4030-bc1e-a1cb28a6de56"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Heron Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 KIT in 1 CARTON (47426-101-06)  / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS", "package_ndc": "47426-101-06", "marketing_start_date": "20160809"}], "brand_name": "SUSTOL", "product_id": "47426-101_d4d4e836-ebba-4666-b6da-9d5a846dfcf8", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "47426-101", "generic_name": "granisetron", "labeler_name": "Heron Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SUSTOL", "active_ingredients": [{"name": "GRANISETRON", "strength": "10 mg/.4mL"}], "application_number": "NDA022445", "marketing_category": "NDA", "marketing_start_date": "20160809", "listing_expiration_date": "20271231"}