ondansetron

Generic: ondansetron

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler a-s medication solutions
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 8 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1128
Product ID 50090-1128_e75d99fb-9d40-4f74-94d6-0e9b5e7a521b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090469
Listing Expiration 2027-12-31
Marketing Start 2010-04-12

Pharmacologic Class

Established (EPC)
serotonin-3 receptor antagonist [epc]
Mechanism of Action
serotonin 3 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500901128
Hyphenated Format 50090-1128

Supplemental Identifiers

RxCUI
104894 312087
UNII
4AF302ESOS
NUI
N0000175817 N0000175818

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 ANDA090469 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (50090-1128-0) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50090-1128-1) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50090-1128-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (50090-1128-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
source: ndc

Packages (4)

50090-1128-0 1 BLISTER PACK in 1 CARTON (50090-1128-0) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 50090-1128-1 1 BLISTER PACK in 1 CARTON (50090-1128-1) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 50090-1128-2 1 BLISTER PACK in 1 CARTON (50090-1128-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK 50090-1128-3 2 BLISTER PACK in 1 CARTON (50090-1128-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Ingredients (1)

ondansetron (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": "e75d99fb-9d40-4f74-94d6-0e9b5e7a521b", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894", "312087"], "spl_set_id": ["378d0963-d026-4478-8202-fbb636904a37"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50090-1128-0)  / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50090-1128-0", "marketing_start_date": "20141128"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50090-1128-1)  / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50090-1128-1", "marketing_start_date": "20141128"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50090-1128-2)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50090-1128-2", "marketing_start_date": "20141128"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50090-1128-3)  / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK", "package_ndc": "50090-1128-3", "marketing_start_date": "20250501"}], "brand_name": "Ondansetron", "product_id": "50090-1128_e75d99fb-9d40-4f74-94d6-0e9b5e7a521b", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "50090-1128", "generic_name": "Ondansetron", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "8 mg/1"}], "application_number": "ANDA090469", "marketing_category": "ANDA", "marketing_start_date": "20100412", "listing_expiration_date": "20271231"}