ondansetron

Generic: ondansetron hydrochloride

Labeler: atlantic biologics corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler atlantic biologics corp.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Atlantic Biologics Corp.

Identifiers & Regulatory

Product NDC 17856-0672
Product ID 17856-0672_41d71d34-d0bc-4d2b-e063-6294a90aa350
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078776
Listing Expiration 2026-12-31
Marketing Start 2007-11-28

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 178560672
Hyphenated Format 17856-0672

Supplemental Identifiers

RxCUI
312085
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 hydrochloride (source: ndc)
Application Number ANDA078776 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 60 SYRINGE in 1 CASE (17856-0672-1) / 2.5 mL in 1 SYRINGE
  • 120 SYRINGE in 1 CASE (17856-0672-2) / 2.5 mL in 1 SYRINGE
  • 120 SYRINGE in 1 CASE (17856-0672-3) / 2.5 mL in 1 SYRINGE
  • 72 CUP, UNIT-DOSE in 1 CASE (17856-0672-4) / 5 mL in 1 CUP, UNIT-DOSE
source: ndc

Packages (4)

17856-0672-1 60 SYRINGE in 1 CASE (17856-0672-1) / 2.5 mL in 1 SYRINGE 17856-0672-2 120 SYRINGE in 1 CASE (17856-0672-2) / 2.5 mL in 1 SYRINGE 17856-0672-3 120 SYRINGE in 1 CASE (17856-0672-3) / 2.5 mL in 1 SYRINGE 17856-0672-4 72 CUP, UNIT-DOSE in 1 CASE (17856-0672-4) / 5 mL in 1 CUP, UNIT-DOSE

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41d71d34-d0bc-4d2b-e063-6294a90aa350", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["41d71d26-0d42-b368-e063-6394a90add43"], "manufacturer_name": ["Atlantic Biologics Corp."]}, "finished": true, "packaging": [{"sample": false, "description": "60 SYRINGE in 1 CASE (17856-0672-1)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-0672-1", "marketing_start_date": "20251023"}, {"sample": false, "description": "120 SYRINGE in 1 CASE (17856-0672-2)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-0672-2", "marketing_start_date": "20251023"}, {"sample": false, "description": "120 SYRINGE in 1 CASE (17856-0672-3)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-0672-3", "marketing_start_date": "20251023"}, {"sample": false, "description": "72 CUP, UNIT-DOSE in 1 CASE (17856-0672-4)  / 5 mL in 1 CUP, UNIT-DOSE", "package_ndc": "17856-0672-4", "marketing_start_date": "20251023"}], "brand_name": "Ondansetron", "product_id": "17856-0672_41d71d34-d0bc-4d2b-e063-6294a90aa350", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "17856-0672", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Atlantic Biologics Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA078776", "marketing_category": "ANDA", "marketing_start_date": "20071128", "listing_expiration_date": "20261231"}