granisetron hydrochloride

Generic: granisetron hydrochloride

Labeler: bionpharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name granisetron hydrochloride
Generic Name granisetron hydrochloride
Labeler bionpharma inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

granisetron hydrochloride 1 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-350
Product ID 69452-350_cfe3b317-aba5-46b3-83fd-df5a6d71ea76
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078678
Listing Expiration 2026-12-31
Marketing Start 2022-02-28

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 69452350
Hyphenated Format 69452-350

Supplemental Identifiers

RxCUI
310599
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 ANDA078678 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (69452-350-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11)
  • 2 BLISTER PACK in 1 CARTON (69452-350-92) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (3)

69452-350-01 2 BLISTER PACK in 1 CARTON (69452-350-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK 69452-350-11 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11) 69452-350-92 2 BLISTER PACK in 1 CARTON (69452-350-92) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

granisetron hydrochloride (1 mg/1)

Linked Drug Pages (1)

Granisetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "cfe3b317-aba5-46b3-83fd-df5a6d71ea76", "openfda": {"unii": ["318F6L70J8"], "rxcui": ["310599"], "spl_set_id": ["50b713d3-7ca8-465a-aefa-65ddbe17b934"], "manufacturer_name": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69452-350-01)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69452-350-01", "marketing_start_date": "20220228"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-350-11)", "package_ndc": "69452-350-11", "marketing_start_date": "20220228"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (69452-350-92)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "69452-350-92", "marketing_start_date": "20220228"}], "brand_name": "Granisetron Hydrochloride", "product_id": "69452-350_cfe3b317-aba5-46b3-83fd-df5a6d71ea76", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "69452-350", "generic_name": "Granisetron Hydrochloride", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron Hydrochloride", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA078678", "marketing_category": "ANDA", "marketing_start_date": "20220228", "listing_expiration_date": "20261231"}