ondansetron

Generic: ondansetron

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler direct_rx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 61919-565
Product ID 61919-565_4b32211f-c9b5-5ea2-e063-6394a90a2834
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2027-12-31
Marketing Start 2019-08-22

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 61919565
Hyphenated Format 61919-565

Supplemental Identifiers

RxCUI
198052
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
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (61919-565-30)
  • 45 TABLET, FILM COATED in 1 BOTTLE (61919-565-45)
source: ndc

Packages (2)

61919-565-30 30 TABLET, FILM COATED in 1 BOTTLE (61919-565-30) 61919-565-45 45 TABLET, FILM COATED in 1 BOTTLE (61919-565-45)

Ingredients (1)

ondansetron hydrochloride (4 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": "4b32211f-c9b5-5ea2-e063-6394a90a2834", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["198052"], "spl_set_id": ["90b73778-2ab5-5460-e053-2a95a90abbc1"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (61919-565-30)", "package_ndc": "61919-565-30", "marketing_start_date": "20190822"}, {"sample": false, "description": "45 TABLET, FILM COATED in 1 BOTTLE (61919-565-45)", "package_ndc": "61919-565-45", "marketing_start_date": "20190822"}], "brand_name": "ONDANSETRON", "product_id": "61919-565_4b32211f-c9b5-5ea2-e063-6394a90a2834", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "61919-565", "generic_name": "ONDANSETRON", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20190822", "listing_expiration_date": "20271231"}