ondansetron hydrochloride

Generic: ondansetron hydrochloride

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

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 62756-130
Product ID 62756-130_e83d90db-54a7-4c13-bd68-b1620a8aecaf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077050
Listing Expiration 2026-12-31
Marketing Start 2007-06-25

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62756130
Hyphenated Format 62756-130

Supplemental Identifiers

RxCUI
104894 198052 312086 312087
UPC
0362756131019 0362756240834 0362756240643 0362756356832 0362756130012
UNII
4AF302ESOS NMH84OZK2B
NUI
N0000175817 N0000175818

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 ondansetron hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA077050 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62756-130-01)
  • 10 BLISTER PACK in 1 DOSE PACK (62756-130-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

62756-130-01 30 TABLET, FILM COATED in 1 BOTTLE (62756-130-01) 62756-130-02 10 BLISTER PACK in 1 DOSE PACK (62756-130-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

ondansetron hydrochloride (4 mg/1)

Linked Drug Pages (1)

ondansetron hydrochloride, ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e83d90db-54a7-4c13-bd68-b1620a8aecaf", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0362756131019", "0362756240834", "0362756240643", "0362756356832", "0362756130012"], "unii": ["4AF302ESOS", "NMH84OZK2B"], "rxcui": ["104894", "198052", "312086", "312087"], "spl_set_id": ["92c758a3-e749-4a15-be4b-ee30b364b2b0"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62756-130-01)", "package_ndc": "62756-130-01", "marketing_start_date": "20070625"}, {"sample": false, "description": "10 BLISTER PACK in 1 DOSE PACK (62756-130-02)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "62756-130-02", "marketing_start_date": "20070625"}], "brand_name": "ondansetron hydrochloride", "product_id": "62756-130_e83d90db-54a7-4c13-bd68-b1620a8aecaf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "62756-130", "generic_name": "ondansetron hydrochloride", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ondansetron hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA077050", "marketing_category": "ANDA", "marketing_start_date": "20070625", "listing_expiration_date": "20261231"}