granisetron hydrochloride

Generic: granisetron hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name granisetron hydrochloride
Generic Name granisetron hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

granisetron hydrochloride 1 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9745
Product ID 0143-9745_3b366664-32e3-4d5c-b75c-0b764ffa31f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078629
Listing Expiration 2026-12-31
Marketing Start 2009-12-23

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 01439745
Hyphenated Format 0143-9745

Supplemental Identifiers

RxCUI
240912 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 ANDA078629 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)
  • 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)
source: ndc

Packages (2)

0143-9745-05 5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01) 0143-9745-10 10 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10) / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)

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": "3b366664-32e3-4d5c-b75c-0b764ffa31f6", "openfda": {"unii": ["318F6L70J8"], "rxcui": ["240912", "1734399"], "spl_set_id": ["e07862df-f324-4575-a1ef-f7e1cbab4c7a"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-05)  / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)", "package_ndc": "0143-9745-05", "marketing_start_date": "20091223"}, {"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (0143-9745-10)  / 4 mL in 1 VIAL, MULTI-DOSE (0143-9745-01)", "package_ndc": "0143-9745-10", "marketing_start_date": "20091223"}], "brand_name": "Granisetron Hydrochloride", "product_id": "0143-9745_3b366664-32e3-4d5c-b75c-0b764ffa31f6", "dosage_form": "INJECTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "0143-9745", "generic_name": "Granisetron Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron Hydrochloride", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA078629", "marketing_category": "ANDA", "marketing_start_date": "20091223", "listing_expiration_date": "20261231"}