FDA.reportPublic FDA data

NDC 0069-5471-01 - CEREBYX

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
0069-5471
Requested NDC
0069-5471-01
Package NDCs from labels
0069-5471-01, 0069-5471-02
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pharmacia & Upjohn Company LLC
Effective date
2025-05-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CEREBYX - Pfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pharmacia & Upjohn Company LLCPfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pharmacia & Upjohn Company LLC2025-05-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-5471-01CEREBYX2 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION229
0069-5471-02CEREBYX25 in 1 CARTONINJECTION, SOLUTION2529

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-5471CEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]29Current NDC, Legacy NDC, 2 package rows20250521_de5a6711-4abb-4c3d-a18b-266b094ace11.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-5471-01ML - Milliliter0069-54714f96b53c-0699-4015-9c79-43531269d2f212015-02-02
0069-5471-02ML - Milliliter0069-54718fd7951c-f98a-4710-be02-dcdf7dd9650b12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]2
PHENYTOINACTIVE MOIETY6158TKW0C5CEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]2
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]2

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
rxcui: 1670200
rxcui: 1670195
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.