granisetron

Generic: granisetron hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name granisetron
Generic Name granisetron hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

granisetron hydrochloride 1 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-318
Product ID 63323-318_fd73c3f4-aa7d-4c2f-ab74-1883910ea086
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078096
Listing Expiration 2026-12-31
Marketing Start 2009-11-20

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 63323318
Hyphenated Format 63323-318

Supplemental Identifiers

RxCUI
240912 543218 1734399
UPC
0363323319045 0363323318017
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 (source: ndc)
Generic Name granisetron hydrochloride (source: ndc)
Application Number ANDA078096 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) / 1 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

63323-318-01 1 VIAL, SINGLE-USE in 1 BOX (63323-318-01) / 1 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

granisetron hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Granisetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fd73c3f4-aa7d-4c2f-ab74-1883910ea086", "openfda": {"upc": ["0363323319045", "0363323318017"], "unii": ["318F6L70J8"], "rxcui": ["240912", "543218", "1734399"], "spl_set_id": ["dddc8714-383f-4bc5-a468-ae89dbc802b4"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 BOX (63323-318-01)  / 1 mL in 1 VIAL, SINGLE-USE", "package_ndc": "63323-318-01", "marketing_start_date": "20091120"}], "brand_name": "Granisetron", "product_id": "63323-318_fd73c3f4-aa7d-4c2f-ab74-1883910ea086", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63323-318", "generic_name": "GRANISETRON HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078096", "marketing_category": "ANDA", "marketing_start_date": "20091120", "listing_expiration_date": "20261231"}