ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron
Labeler remedyrepack inc.
Dosage Form TABLET, ORALLY DISINTEGRATING
Routes
ORAL
Active Ingredients

ondansetron 4 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3512
Product ID 70518-3512_4c0e1324-ec05-d48e-e063-6294a90af1c3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078152
Listing Expiration 2027-12-31
Marketing Start 2022-09-07

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 705183512
Hyphenated Format 70518-3512

Supplemental Identifiers

RxCUI
104894
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 ANDA078152 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-0)
  • 6 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-1)
  • 9 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-5)
  • 15 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-7)
  • 3 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-8)
source: ndc

Packages (5)

70518-3512-0 30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-0) 70518-3512-1 6 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-1) 70518-3512-5 9 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-5) 70518-3512-7 15 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-7) 70518-3512-8 3 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-8)

Ingredients (1)

ondansetron (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": "4c0e1324-ec05-d48e-e063-6294a90af1c3", "openfda": {"nui": ["N0000175817", "N0000175818"], "unii": ["4AF302ESOS"], "rxcui": ["104894"], "spl_set_id": ["c0d827d0-333f-4187-ac75-9dc7d34b6169"], "pharm_class_epc": ["Serotonin-3 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Serotonin 3 Receptor Antagonists [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-0)", "package_ndc": "70518-3512-0", "marketing_start_date": "20220907"}, {"sample": false, "description": "6 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-1)", "package_ndc": "70518-3512-1", "marketing_start_date": "20220929"}, {"sample": false, "description": "9 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-5)", "package_ndc": "70518-3512-5", "marketing_start_date": "20231223"}, {"sample": false, "description": "15 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-7)", "package_ndc": "70518-3512-7", "marketing_start_date": "20250306"}, {"sample": false, "description": "3 TABLET, ORALLY DISINTEGRATING in 1 BOX, UNIT-DOSE (70518-3512-8)", "package_ndc": "70518-3512-8", "marketing_start_date": "20250724"}], "brand_name": "Ondansetron", "product_id": "70518-3512_4c0e1324-ec05-d48e-e063-6294a90af1c3", "dosage_form": "TABLET, ORALLY DISINTEGRATING", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "70518-3512", "generic_name": "Ondansetron", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON", "strength": "4 mg/1"}], "application_number": "ANDA078152", "marketing_category": "ANDA", "marketing_start_date": "20220907", "listing_expiration_date": "20271231"}