ondansetron hydrochloride

Generic: ondansetron hydrochloride

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

Drug Facts

Product Profile

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

ondansetron hydrochloride 8 mg/1

Manufacturer
Pharmpak, Inc.

Identifiers & Regulatory

Product NDC 54348-821
Product ID 54348-821_eaa58b56-e847-aab7-e053-2995a90a49c2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078539
Listing Expiration 2026-12-31
Marketing Start 2019-08-08

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 54348821
Hyphenated Format 54348-821

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 hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA078539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (54348-821-00) / 1 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-821-02) / 2 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-821-04) / 4 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 BOX (54348-821-05) / 5 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (4)

54348-821-00 1 BOTTLE in 1 BOX (54348-821-00) / 1 TABLET, FILM COATED in 1 BOTTLE 54348-821-02 1 BOTTLE in 1 BOX (54348-821-02) / 2 TABLET, FILM COATED in 1 BOTTLE 54348-821-04 1 BOTTLE in 1 BOX (54348-821-04) / 4 TABLET, FILM COATED in 1 BOTTLE 54348-821-05 1 BOTTLE in 1 BOX (54348-821-05) / 5 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

ondansetron hydrochloride (8 mg/1)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "eaa58b56-e847-aab7-e053-2995a90a49c2", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["e41b9469-e844-47d9-933a-4c9f4453ecc7"], "manufacturer_name": ["Pharmpak, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (54348-821-00)  / 1 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-821-00", "marketing_start_date": "20190808"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-821-02)  / 2 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-821-02", "marketing_start_date": "20190808"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-821-04)  / 4 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-821-04", "marketing_start_date": "20190808"}, {"sample": false, "description": "1 BOTTLE in 1 BOX (54348-821-05)  / 5 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "54348-821-05", "marketing_start_date": "20190808"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "54348-821_eaa58b56-e847-aab7-e053-2995a90a49c2", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "54348-821", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Pharmpak, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA078539", "marketing_category": "ANDA", "marketing_start_date": "20190808", "listing_expiration_date": "20261231"}