ondansetron

Generic: ondansetron

Labeler: sportpharm llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler sportpharm llc
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
Sportpharm LLC

Identifiers & Regulatory

Product NDC 85766-038
Product ID 85766-038_4a2b4364-9eaf-2994-e063-6394a90aa9bf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2027-12-31
Marketing Start 2010-04-12

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 85766038
Hyphenated Format 85766-038

Supplemental Identifiers

RxCUI
312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA090469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (85766-038-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (85766-038-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (85766-038-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (85766-038-20) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 24 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85766-038-24)
  • 3 BLISTER PACK in 1 CARTON (85766-038-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (6)

85766-038-04 1 BLISTER PACK in 1 CARTON (85766-038-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 85766-038-06 1 BLISTER PACK in 1 CARTON (85766-038-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 85766-038-10 1 BLISTER PACK in 1 CARTON (85766-038-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 85766-038-20 2 BLISTER PACK in 1 CARTON (85766-038-20) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 85766-038-24 24 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85766-038-24) 85766-038-30 3 BLISTER PACK in 1 CARTON (85766-038-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

ondansetron (8 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": "4a2b4364-9eaf-2994-e063-6394a90aa9bf", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["312087"], "spl_set_id": ["3c4cda2f-13d9-42c5-b449-77deb06c8de5"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["Sportpharm LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (85766-038-04)  / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "85766-038-04", "marketing_start_date": "20250807"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (85766-038-06)  / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "85766-038-06", "marketing_start_date": "20250807"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (85766-038-10)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "85766-038-10", "marketing_start_date": "20250807"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (85766-038-20)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "85766-038-20", "marketing_start_date": "20250807"}, {"sample": false, "description": "24 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85766-038-24)", "package_ndc": "85766-038-24", "marketing_start_date": "20251003"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (85766-038-30)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "85766-038-30", "marketing_start_date": "20250807"}], "brand_name": "Ondansetron", "product_id": "85766-038_4a2b4364-9eaf-2994-e063-6394a90aa9bf", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "85766-038", "generic_name": "Ondansetron", "labeler_name": "Sportpharm LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20100412", "listing_expiration_date": "20271231"}