ondansetron

Generic: ondansetron

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-691
Product ID 65162-691_7421d60d-7d82-4ec5-885a-255c507c32a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091483
Listing Expiration 2026-12-31
Marketing Start 2010-12-17

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 65162691
Hyphenated Format 65162-691

Supplemental Identifiers

RxCUI
312085
UPC
0365162691795
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
  • 10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19) / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37)
  • 50 mL in 1 BOTTLE (65162-691-79)
source: ndc

Packages (2)

65162-691-19 10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19) / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37) 65162-691-79 50 mL in 1 BOTTLE (65162-691-79)

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": "7421d60d-7d82-4ec5-885a-255c507c32a4", "openfda": {"upc": ["0365162691795"], "unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["38435346-d505-4bdd-bbc6-a7bcba411033"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 CUP, UNIT-DOSE in 1 TRAY (65162-691-19)  / 5 mL in 1 CUP, UNIT-DOSE (65162-691-37)", "package_ndc": "65162-691-19", "marketing_start_date": "20101217"}, {"sample": false, "description": "50 mL in 1 BOTTLE (65162-691-79)", "package_ndc": "65162-691-79", "marketing_start_date": "20101217"}], "brand_name": "Ondansetron", "product_id": "65162-691_7421d60d-7d82-4ec5-885a-255c507c32a4", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "65162-691", "generic_name": "Ondansetron", "labeler_name": "Amneal Pharmaceuticals LLC", "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": "20101217", "listing_expiration_date": "20261231"}