granisetron hydrochloride

Generic: granisetron hydrochloride

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name granisetron hydrochloride
Generic Name granisetron hydrochloride
Labeler mylan institutional llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

granisetron hydrochloride 1 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-863
Product ID 67457-863_9baf50f5-8a78-4532-af34-57f5d0c74dae
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091136
Listing Expiration 2027-12-31
Marketing Start 2018-03-21

Pharmacologic Class

Classes
serotonin 3 receptor antagonists [moa] serotonin-3 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457863
Hyphenated Format 67457-863

Supplemental Identifiers

RxCUI
240912 543218 1734399
UNII
318F6L70J8

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 granisetron hydrochloride (source: ndc)
Generic Name granisetron hydrochloride (source: ndc)
Application Number ANDA091136 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIAL
source: ndc

Packages (1)

67457-863-01 1 VIAL in 1 CARTON (67457-863-01) / 1 mL in 1 VIAL

Ingredients (1)

granisetron hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Granisetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "9baf50f5-8a78-4532-af34-57f5d0c74dae", "openfda": {"unii": ["318F6L70J8"], "rxcui": ["240912", "543218", "1734399"], "spl_set_id": ["8d88adba-7f5e-4e97-84b3-6ca8ec98c023"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (67457-863-01)  / 1 mL in 1 VIAL", "package_ndc": "67457-863-01", "marketing_start_date": "20180321"}], "brand_name": "Granisetron Hydrochloride", "product_id": "67457-863_9baf50f5-8a78-4532-af34-57f5d0c74dae", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "67457-863", "generic_name": "Granisetron Hydrochloride", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron Hydrochloride", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA091136", "marketing_category": "ANDA", "marketing_start_date": "20180321", "listing_expiration_date": "20271231"}