ondansetron

Generic: ondansetron

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-4245
Product ID 70518-4245_4007a856-78ce-2f62-e063-6394a90a1045
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2024-12-20

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 705184245
Hyphenated Format 70518-4245

Supplemental Identifiers

RxCUI
312086
UNII
NMH84OZK2B

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 ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4245-0)
source: ndc

Packages (1)

70518-4245-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4245-0)

Ingredients (1)

ondansetron hydrochloride (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": "4007a856-78ce-2f62-e063-6394a90a1045", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["416be720-82e8-4a6d-8531-c1a29869daae"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4245-0)", "package_ndc": "70518-4245-0", "marketing_start_date": "20241220"}], "brand_name": "Ondansetron", "product_id": "70518-4245_4007a856-78ce-2f62-e063-6394a90a1045", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "70518-4245", "generic_name": "Ondansetron", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20241220", "listing_expiration_date": "20261231"}