FDA.reportPublic FDA data

NDC 0143-9782-01 - Fosphenytoin Sodium

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
0143-9782
Requested NDC
0143-9782-01
Package NDCs from labels
0143-9782-01, 0143-9782-10
Manufacturer
West-Ward Pharmaceuticals Corp | HIKMA FARMACEUTICA (PORTUGAL), S.A
Effective date
2018-01-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENYTOIN - West-Ward Pharmaceuticals Corp | HIKMA FARMACEUTICA (PORTUGAL), S.AWest-Ward Pharmaceuticals Corp | HIKMA FARMACEUTICA (PORTUGAL), S.A2018-01-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9782-01Fosphenytoin Sodium10 mL in 1 VIALINJECTION, SOLUTION1010
0143-9782-10Fosphenytoin Sodium10 in 1 PACKAGEINJECTION, SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9782FOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICALS CORP]10Current NDC, Legacy NDC, 2 package rows20180108_c92df63b-5140-4213-8d43-8327ff6230b7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9782-01ML - Milliliter0143-9782b4373854-aff7-4bc7-b943-7f91768eaf7f12018-07-03
0143-9782-10ML - Milliliter0143-97823f8fb31f-5727-4f57-abd8-20c7b39d101012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
PHENYTOINACTIVE MOIETY6158TKW0C5FOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7
WATERINACTIVE INGREDIENT059QF0KO0RFOSPHENYTOIN SODIUM INJECTION, SOLUTION [WEST-WARD PHARMACEUTICAL CORP]7

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 11 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Fosphenytoin SodiumFOSPHENYTOIN SODIUMWest-Ward Pharmaceuticals Corpc92df63b-5140-4213-8d43-8327ff6230b72018-01-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA078765
ndc (package): 0143-9788-01
ndc (package): 0143-9782-01
ndc (package): 0143-9788-25
ndc (package): 0143-9782-10
ndc (product): 0143-9788
ndc (product): 0143-9782
ndc11 (package): 00143978201
rxcui: 1670200
rxcui: 1670195
spl id: 6b56fe59-9fb1-410b-b57c-7ada1662136a
spl set id: c92df63b-5140-4213-8d43-8327ff6230b7
unii: 7VLR55452Z
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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