ondansetron

Generic: ondansetron

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

Drug Facts

Product Profile

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

ondansetron hydrochloride 4 mg/5mL

Manufacturer
ATLANTIC BIOLOGICALS CORP.

Identifiers & Regulatory

Product NDC 17856-0691
Product ID 17856-0691_3633ef65-d53d-4728-e063-6394a90a6205
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091483
Listing Expiration 2026-12-31
Marketing Start 2010-12-17

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 178560691
Hyphenated Format 17856-0691

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 (source: ndc)
Application Number ANDA091483 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 1.5 mL in 1 SYRINGE (17856-0691-1)
  • 2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2)
  • 2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-4)
  • 5 mL in 1 CUP (17856-0691-5)
  • 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-6) / 1.25 mL in 1 SYRINGE
  • 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-7) / 1.9 mL in 1 SYRINGE
  • 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-8) / 2.5 mL in 1 SYRINGE
source: ndc

Packages (7)

17856-0691-1 1.5 mL in 1 SYRINGE (17856-0691-1) 17856-0691-2 2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2) 17856-0691-4 2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-4) 17856-0691-5 5 mL in 1 CUP (17856-0691-5) 17856-0691-6 120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-6) / 1.25 mL in 1 SYRINGE 17856-0691-7 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-7) / 1.9 mL in 1 SYRINGE 17856-0691-8 60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-8) / 2.5 mL in 1 SYRINGE

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": "3633ef65-d53d-4728-e063-6394a90a6205", "openfda": {"unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["e5ab38a2-5921-4320-a313-e0080c078046"], "manufacturer_name": ["ATLANTIC BIOLOGICALS CORP."]}, "finished": true, "packaging": [{"sample": false, "description": "1.5 mL in 1 SYRINGE (17856-0691-1)", "package_ndc": "17856-0691-1", "marketing_start_date": "20240417"}, {"sample": false, "description": "2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-2)", "package_ndc": "17856-0691-2", "marketing_start_date": "20240417"}, {"sample": false, "description": "2.5 mL in 1 SYRINGE, PLASTIC (17856-0691-4)", "package_ndc": "17856-0691-4", "marketing_start_date": "20240417"}, {"sample": false, "description": "5 mL in 1 CUP (17856-0691-5)", "package_ndc": "17856-0691-5", "marketing_start_date": "20240417"}, {"sample": false, "description": "120 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-6)  / 1.25 mL in 1 SYRINGE", "package_ndc": "17856-0691-6", "marketing_start_date": "20240417"}, {"sample": false, "description": "48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-7)  / 1.9 mL in 1 SYRINGE", "package_ndc": "17856-0691-7", "marketing_start_date": "20240417"}, {"sample": false, "description": "60 SYRINGE in 1 BOX, UNIT-DOSE (17856-0691-8)  / 2.5 mL in 1 SYRINGE", "package_ndc": "17856-0691-8", "marketing_start_date": "20240417"}], "brand_name": "Ondansetron", "product_id": "17856-0691_3633ef65-d53d-4728-e063-6394a90a6205", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "17856-0691", "generic_name": "Ondansetron", "labeler_name": "ATLANTIC BIOLOGICALS CORP.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA091483", "marketing_category": "ANDA", "marketing_start_date": "20101217", "listing_expiration_date": "20261231"}