FDA.reportPublic FDA data

CEREBYX

Product NDC
0069-5474
11-digit product format
000695474
Labeler code
0069
Product ID
0069-5474_fcfe3e97-071d-44d8-8235-bb6b67567c18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA020450
Marketing category
NDA
Marketing start
2013-10-28
Substance
FOSPHENYTOIN SODIUM
Active strength
50 mg/mL
Pharmacologic classes
Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 2D6 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CEREBYX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7VLR55452Z
Rxcui1670195, 1670197, 1670200, 1670201

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-5474-01CEREBYX10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1029
0069-5474-02CEREBYX10 in 1 PACKAGEINJECTION, SOLUTION1029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-5474-01ML - Milliliter0069-54743ae65265-9d54-47b8-bd3f-a2061772b52d12015-02-02
0069-5474-02ML - Milliliter0069-5474e9a0b6e1-aaae-4141-a81e-817b22f0c92412015-02-02

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-5474CEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]29Current NDC, Legacy NDC, 2 package rows20250521_de5a6711-4abb-4c3d-a18b-266b094ace11.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670201Cerebyx 100 MG PE in 2 ML InjectionPSNde5a6711-4abb-4c3d-a18b-266b094ace1129
1670197Cerebyx 500 MG PE in 10 ML InjectionPSNde5a6711-4abb-4c3d-a18b-266b094ace1129
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSNde5a6711-4abb-4c3d-a18b-266b094ace1129
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSNde5a6711-4abb-4c3d-a18b-266b094ace1129
167019710 ML fosphenytoin sodium 75 MG/ML Injection [Cerebyx]SBDde5a6711-4abb-4c3d-a18b-266b094ace1129
16702012 ML fosphenytoin sodium 75 MG/ML Injection [Cerebyx]SBDde5a6711-4abb-4c3d-a18b-266b094ace1129
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCDde5a6711-4abb-4c3d-a18b-266b094ace1129
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCDde5a6711-4abb-4c3d-a18b-266b094ace1129
167019710 ML Cerebyx 75 MG/ML InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
16702012 ML Cerebyx 75 MG/ML InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
1670201Cerebyx 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
1670197Cerebyx 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYde5a6711-4abb-4c3d-a18b-266b094ace1129

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-5474-010006954740110 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
0069-5474-020006954740210 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-5474-02) / 10 mL in 1 VIAL, SINGLE-DOSE (0069-5474-01) 2013-10-280000-00-00NoNoCurrent