ondansetron

Generic: ondansetron

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler avpak
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-647
Product ID 50268-647_47fb3120-1cb0-55b8-e063-6394a90a662a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091483
Listing Expiration 2027-12-31
Marketing Start 2023-09-20

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 50268647
Hyphenated Format 50268-647

Supplemental Identifiers

RxCUI
312085
UNII
NMH84OZK2B

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 ANDA091483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 40 CUP, UNIT-DOSE in 1 TRAY (50268-647-14) / 5 mL in 1 CUP, UNIT-DOSE (50268-647-11)
source: ndc

Packages (1)

50268-647-14 40 CUP, UNIT-DOSE in 1 TRAY (50268-647-14) / 5 mL in 1 CUP, UNIT-DOSE (50268-647-11)

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47fb3120-1cb0-55b8-e063-6394a90a662a", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["05cf8d4f-ac57-4177-e063-6394a90ae804"], "manufacturer_name": ["AvPAK"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CUP, UNIT-DOSE in 1 TRAY (50268-647-14)  / 5 mL in 1 CUP, UNIT-DOSE (50268-647-11)", "package_ndc": "50268-647-14", "marketing_start_date": "20230920"}], "brand_name": "Ondansetron", "product_id": "50268-647_47fb3120-1cb0-55b8-e063-6394a90a662a", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "50268-647", "generic_name": "Ondansetron", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA091483", "marketing_category": "ANDA", "marketing_start_date": "20230920", "listing_expiration_date": "20271231"}