ondansetron

Generic: ondansetron

Labeler: ipca laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler ipca laboratories limited
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 4 mg/1

Manufacturer
Ipca Laboratories Limited

Identifiers & Regulatory

Product NDC 83980-012
Product ID 83980-012_3582cf26-d9a0-4b93-93a1-d1824e55fc19
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209389
Listing Expiration 2026-12-31
Marketing Start 2025-06-19

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 83980012
Hyphenated Format 83980-012

Supplemental Identifiers

RxCUI
104894 312087
UPC
0383980012134 0383980013131
UNII
4AF302ESOS
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 (source: ndc)
Generic Name ondansetron (source: ndc)
Application Number ANDA209389 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-01)
  • 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-10)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-13)
  • 3 BLISTER PACK in 1 CARTON (83980-012-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (4)

83980-012-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-01) 83980-012-10 1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-10) 83980-012-13 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-13) 83980-012-83 3 BLISTER PACK in 1 CARTON (83980-012-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

ondansetron (4 mg/1)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3582cf26-d9a0-4b93-93a1-d1824e55fc19", "openfda": {"nui": ["N0000175817", "N0000175818"], "upc": ["0383980012134", "0383980013131"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["8e24f935-87fe-4b6a-b265-60b1039f38d5"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Ipca Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-01)", "package_ndc": "83980-012-01", "marketing_start_date": "20250619"}, {"sample": false, "description": "1000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-10)", "package_ndc": "83980-012-10", "marketing_start_date": "20250619"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-13)", "package_ndc": "83980-012-13", "marketing_start_date": "20250619"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (83980-012-83)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "83980-012-83", "marketing_start_date": "20250619"}], "brand_name": "Ondansetron", "product_id": "83980-012_3582cf26-d9a0-4b93-93a1-d1824e55fc19", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "83980-012", "generic_name": "Ondansetron", "labeler_name": "Ipca Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "4 mg/1"}], "application_number": "ANDA209389", "marketing_category": "ANDA", "marketing_start_date": "20250619", "listing_expiration_date": "20261231"}