granisetron hydrochloride

Generic: granisetron hydrochloride

Labeler: natco pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name granisetron hydrochloride
Generic Name granisetron hydrochloride
Labeler natco pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

granisetron hydrochloride 1 mg/1

Manufacturer
Natco Pharma Limited

Identifiers & Regulatory

Product NDC 63850-0005
Product ID 63850-0005_67953305-4eb0-4b00-abae-716ac25c5bf9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078969
Listing Expiration 2026-12-31
Marketing Start 2009-06-22

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 638500005
Hyphenated Format 63850-0005

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 ANDA078969 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1)
  • 2 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2)
source: ndc

Packages (2)

63850-0005-1 10 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1) 63850-0005-2 2 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2)

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": "67953305-4eb0-4b00-abae-716ac25c5bf9", "openfda": {"unii": ["318F6L70J8"], "rxcui": ["310599"], "spl_set_id": ["d2be8de3-04fe-4e92-82b4-98d749b89596"], "manufacturer_name": ["Natco Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-1)", "package_ndc": "63850-0005-1", "marketing_start_date": "20090622"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BLISTER PACK (63850-0005-2)", "package_ndc": "63850-0005-2", "marketing_start_date": "20090622"}], "brand_name": "Granisetron hydrochloride", "product_id": "63850-0005_67953305-4eb0-4b00-abae-716ac25c5bf9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "63850-0005", "generic_name": "Granisetron hydrochloride", "labeler_name": "Natco Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Granisetron hydrochloride", "active_ingredients": [{"name": "GRANISETRON HYDROCHLORIDE", "strength": "1 mg/1"}], "application_number": "ANDA078969", "marketing_category": "ANDA", "marketing_start_date": "20090622", "listing_expiration_date": "20261231"}