granisetron hydrochloride

Generic: granisetron hydrochloride

Labeler: breckenridge pharmaceutical, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name granisetron hydrochloride
Generic Name granisetron hydrochloride
Labeler breckenridge pharmaceutical, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

granisetron hydrochloride 1 mg/1

Manufacturer
Breckenridge Pharmaceutical, Inc.

Identifiers & Regulatory

Product NDC 51991-735
Product ID 51991-735_1919cca7-47e5-4474-8ad1-a49275d4f85b
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 51991735
Hyphenated Format 51991-735

Supplemental Identifiers

RxCUI
310599
UPC
0351991735328
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
  • 2 BLISTER PACK in 1 CARTON (51991-735-20) / 10 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (51991-735-32) / 2 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

51991-735-20 2 BLISTER PACK in 1 CARTON (51991-735-20) / 10 TABLET in 1 BLISTER PACK 51991-735-32 1 BLISTER PACK in 1 CARTON (51991-735-32) / 2 TABLET 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": "1919cca7-47e5-4474-8ad1-a49275d4f85b", "openfda": {"upc": ["0351991735328"], "unii": ["318F6L70J8"], "rxcui": ["310599"], "spl_set_id": ["df4b6775-4337-41e0-815a-b064d98c3fe1"], "manufacturer_name": ["Breckenridge Pharmaceutical, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (51991-735-20)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "51991-735-20", "marketing_start_date": "20090622"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (51991-735-32)  / 2 TABLET in 1 BLISTER PACK", "package_ndc": "51991-735-32", "marketing_start_date": "20090622"}], "brand_name": "Granisetron Hydrochloride", "product_id": "51991-735_1919cca7-47e5-4474-8ad1-a49275d4f85b", "dosage_form": "TABLET", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "51991-735", "generic_name": "Granisetron Hydrochloride", "labeler_name": "Breckenridge Pharmaceutical, Inc.", "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"}