FDA.reportPublic FDA data

NDC 0143-9891-01 - Ondansetron

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0143-9891
Requested NDC
0143-9891-01
Package NDCs from labels
0143-9891-01, 0143-9891-25
Manufacturer
West-Ward Pharmaceuticals Corp | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2018-12-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ondansetron - West-Ward Pharmaceuticals Corp | HIKMA FARMACEUTICA (PORTUGAL), S.AWest-Ward Pharmaceuticals Corp | HIKMA FARMACEUTICA (PORTUGAL), S.A2018-12-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9891-01Ondansetron2 mL in 1 VIAL, SINGLE-DOSEINJECTION215
0143-9891-25Ondansetron25 in 1 CARTONINJECTION2515

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9891ONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]15Current NDC, Legacy NDC, 2 package rows20181215_bb4bc810-db26-471b-9ce7-6e2fb3018af0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9891-01ML - Milliliter0143-98914d0f804a-e1f7-43d1-b04d-e5b2934bbc8512018-05-09
0143-9891-25ML - Milliliter0143-9891d4c271d1-82f7-4b01-b665-a20c09f15e4e12013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON INJECTION [WEST-WARD PHARMACEUTICALS CORP]13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 63 · 1,244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ondansetronONDANSETRON HYDROCHLORIDECardinal Health 107, LLCcb02f2d7-31a9-4f12-880e-7ce7d85440d42026-07-17Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEBryant Ranch Prepack3f2e8efe-7fd4-407c-a77b-bd6dd04608e22026-07-10Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEREMEDYREPACK INC.ee3e8cbe-4f0b-4361-a1b5-8329d85a29322026-07-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
Ondansetron HydrochlorideONDANSETRON HYDROCHLORIDEUnit Dose Solutions, Inc.561dce26-92fa-e00b-e063-6294a90a1ab22026-07-08Warnings, Adverse reactionsExact identifier
unii: NMH84OZK2B
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
ONDANSETRONONDANSETRONSportpharm LLCde72f1ec-75dd-4659-a1a0-32b28b72c7992026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 1740467
unii: NMH84OZK2B
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.