Ondansetron

Generic: Ondansetron

Labeler: ASCLEMED USA INC.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name Ondansetron
Generic Name Ondansetron
Labeler ASCLEMED USA INC.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ONDANSETRON 8 mg/1

Identifiers & Regulatory

Product NDC 76420-949
Product ID 76420-949_411a81e2-5c3d-630f-e063-6294a90a70fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2026-12-31
Marketing Start 2010-04-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420949
Hyphenated Format 76420-949

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
  • 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-01)
  • 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-10)
  • 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-20)
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-30)
  • 3 BLISTER PACK in 1 CARTON (76420-949-33) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-60)
  • 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-90)
source: ndc

Packages (7)

76420-949-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-01) 76420-949-10 10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-10) 76420-949-20 20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-20) 76420-949-30 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-30) 76420-949-33 3 BLISTER PACK in 1 CARTON (76420-949-33) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 76420-949-60 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-60) 76420-949-90 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-90)

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": "411a81e2-5c3d-630f-e063-6294a90a70fa", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["312087"], "spl_set_id": ["52921715-93c9-4e84-a3aa-b3271607c8f8"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["ASCLEMED USA INC."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-01)", "package_ndc": "76420-949-01", "marketing_start_date": "20251014"}, {"sample": false, "description": "10 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-10)", "package_ndc": "76420-949-10", "marketing_start_date": "20251014"}, {"sample": false, "description": "20 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-20)", "package_ndc": "76420-949-20", "marketing_start_date": "20251014"}, {"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-30)", "package_ndc": "76420-949-30", "marketing_start_date": "20251014"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (76420-949-33)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "76420-949-33", "marketing_start_date": "20251014"}, {"sample": false, "description": "60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-60)", "package_ndc": "76420-949-60", "marketing_start_date": "20251014"}, {"sample": false, "description": "90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-949-90)", "package_ndc": "76420-949-90", "marketing_start_date": "20251014"}], "brand_name": "Ondansetron", "product_id": "76420-949_411a81e2-5c3d-630f-e063-6294a90a70fa", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "76420-949", "generic_name": "Ondansetron", "labeler_name": "ASCLEMED USA INC.", "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": "20261231"}