ondansetron

Generic: ondansetron

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 8 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-770
Product ID 43063-770_48d46d34-3176-1749-e063-6394a90a9a42
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077535
Listing Expiration 2027-12-31
Marketing Start 2007-06-25

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 43063770
Hyphenated Format 43063-770

Supplemental Identifiers

RxCUI
312086
UPC
0343063770061
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 ANDA077535 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-770-06)
source: ndc

Packages (1)

43063-770-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-770-06)

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": "48d46d34-3176-1749-e063-6394a90a9a42", "openfda": {"upc": ["0343063770061"], "unii": ["NMH84OZK2B"], "rxcui": ["312086"], "spl_set_id": ["15d0a711-ef3b-4d93-8fbc-17a45f96af8a"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-770-06)", "package_ndc": "43063-770-06", "marketing_start_date": "20140303"}], "brand_name": "Ondansetron", "product_id": "43063-770_48d46d34-3176-1749-e063-6394a90a9a42", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "43063-770", "generic_name": "Ondansetron", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "8 mg/1"}], "application_number": "ANDA077535", "marketing_category": "ANDA", "marketing_start_date": "20070625", "listing_expiration_date": "20271231"}