granisetron hydrochloride

Generic: granisetron hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

granisetron hydrochloride 4 mg/4mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-176
Product ID 55150-176_4dc2ec1d-ed65-481b-bc48-fae589eae213
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204238
Listing Expiration 2026-12-31
Marketing Start 2016-07-06

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 55150176
Hyphenated Format 55150-176

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 ANDA204238 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4 mg/4mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) / 4 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

55150-176-04 1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04) / 4 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

granisetron hydrochloride (4 mg/4mL)

Linked Drug Pages (1)

Granisetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "4dc2ec1d-ed65-481b-bc48-fae589eae213", "openfda": {"unii": ["318F6L70J8"], "rxcui": ["240912", "1734399"], "spl_set_id": ["783e9d68-2371-4fd4-8d7a-a5e36f8718d0"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (55150-176-04)  / 4 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-176-04", "marketing_start_date": "20160706"}], "brand_name": "Granisetron Hydrochloride", "product_id": "55150-176_4dc2ec1d-ed65-481b-bc48-fae589eae213", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "55150-176", "generic_name": "Granisetron Hydrochloride", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron Hydrochloride", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": "4 mg/4mL"}], "application_number": "ANDA204238", "marketing_category": "ANDA", "marketing_start_date": "20160706", "listing_expiration_date": "20261231"}