ondansetron hydrochloride

Generic: ondansetron hydrochloride

Labeler: chartwell rx, llc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ondansetron hydrochloride
Generic Name ondansetron hydrochloride
Labeler chartwell rx, llc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

ondansetron hydrochloride 4 mg/5mL

Manufacturer
Chartwell RX, LLC.

Identifiers & Regulatory

Product NDC 62135-555
Product ID 62135-555_476a94c7-d201-ccb7-e063-6294a90a8cd9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091342
Listing Expiration 2027-12-31
Marketing Start 2011-01-27

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 62135555
Hyphenated Format 62135-555

Supplemental Identifiers

RxCUI
312085
UPC
0362135555580
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 hydrochloride (source: ndc)
Generic Name ondansetron hydrochloride (source: ndc)
Application Number ANDA091342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/5mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-555-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-555-45)
  • 50 mL in 1 BOTTLE (62135-555-58)
source: ndc

Packages (2)

62135-555-24 2 TRAY in 1 BOX (62135-555-24) / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-555-45) 62135-555-58 50 mL in 1 BOTTLE (62135-555-58)

Ingredients (1)

ondansetron hydrochloride (4 mg/5mL)

Linked Drug Pages (1)

Ondansetron Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "476a94c7-d201-ccb7-e063-6294a90a8cd9", "openfda": {"upc": ["0362135555580"], "unii": ["NMH84OZK2B"], "rxcui": ["312085"], "spl_set_id": ["2086bae8-7c3c-4663-93ac-c86407c524c2"], "manufacturer_name": ["Chartwell RX, LLC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-555-24)  / 10 PACKAGE in 1 TRAY / 5 mL in 1 PACKAGE (62135-555-45)", "package_ndc": "62135-555-24", "marketing_start_date": "20240528"}, {"sample": false, "description": "50 mL in 1 BOTTLE (62135-555-58)", "package_ndc": "62135-555-58", "marketing_start_date": "20221004"}], "brand_name": "Ondansetron Hydrochloride", "product_id": "62135-555_476a94c7-d201-ccb7-e063-6294a90a8cd9", "dosage_form": "SOLUTION", "pharm_class": ["Serotonin 3 Receptor Antagonists [MoA]", "Serotonin-3 Receptor Antagonist [EPC]"], "product_ndc": "62135-555", "generic_name": "Ondansetron Hydrochloride", "labeler_name": "Chartwell RX, LLC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ondansetron Hydrochloride", "active_ingredients": [{"name": "ONDANSETRON HYDROCHLORIDE", "strength": "4 mg/5mL"}], "application_number": "ANDA091342", "marketing_category": "ANDA", "marketing_start_date": "20110127", "listing_expiration_date": "20271231"}