ondansetron

Generic: ondansetron hydrochloride

Labeler: dr. reddy's laboratories limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron
Generic Name ondansetron hydrochloride
Labeler dr. reddy's laboratories limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/1

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-153
Product ID 55111-153_b5be4b6c-42cd-c9b3-a0df-e15c946ec89b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076183
Listing Expiration 2026-12-31
Marketing Start 2006-12-26

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 55111153
Hyphenated Format 55111-153

Supplemental Identifiers

RxCUI
198052 312084 312086
UPC
0355111153306 0355111154303
UNII
NMH84OZK2B

Packaging Origin

Original Packager
true

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 ANDA076183 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (55111-153-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (55111-153-05)
  • 3 DOSE PACK in 1 BOX (55111-153-13) / 1 TABLET, FILM COATED in 1 DOSE PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (55111-153-30)
  • 10 DOSE PACK in 1 BOX (55111-153-78) / 10 TABLET, FILM COATED in 1 DOSE PACK
source: ndc

Packages (5)

55111-153-01 100 TABLET, FILM COATED in 1 BOTTLE (55111-153-01) 55111-153-05 500 TABLET, FILM COATED in 1 BOTTLE (55111-153-05) 55111-153-13 3 DOSE PACK in 1 BOX (55111-153-13) / 1 TABLET, FILM COATED in 1 DOSE PACK 55111-153-30 30 TABLET, FILM COATED in 1 BOTTLE (55111-153-30) 55111-153-78 10 DOSE PACK in 1 BOX (55111-153-78) / 10 TABLET, FILM COATED in 1 DOSE PACK

Ingredients (1)

ondansetron hydrochloride (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": "b5be4b6c-42cd-c9b3-a0df-e15c946ec89b", "openfda": {"upc": ["0355111153306", "0355111154303"], "unii": ["NMH84OZK2B"], "rxcui": ["198052", "312084", "312086"], "spl_set_id": ["162f2088-9fb1-47e7-b88c-45104be7e7bb"], "manufacturer_name": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (55111-153-01)", "package_ndc": "55111-153-01", "marketing_start_date": "20061226"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (55111-153-05)", "package_ndc": "55111-153-05", "marketing_start_date": "20061226"}, {"sample": false, "description": "3 DOSE PACK in 1 BOX (55111-153-13)  / 1 TABLET, FILM COATED in 1 DOSE PACK", "package_ndc": "55111-153-13", "marketing_start_date": "20061226"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55111-153-30)", "package_ndc": "55111-153-30", "marketing_start_date": "20061226"}, {"sample": false, "description": "10 DOSE PACK in 1 BOX (55111-153-78)  / 10 TABLET, FILM COATED in 1 DOSE PACK", "package_ndc": "55111-153-78", "marketing_start_date": "20061226"}], "brand_name": "ONDANSETRON", "product_id": "55111-153_b5be4b6c-42cd-c9b3-a0df-e15c946ec89b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "55111-153", "generic_name": "ONDANSETRON HYDROCHLORIDE", "labeler_name": "Dr. Reddy's Laboratories Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ONDANSETRON", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/1"}], "application_number": "ANDA076183", "marketing_category": "ANDA", "marketing_start_date": "20061226", "listing_expiration_date": "20261231"}