FDA.reportPublic FDA data

CEREBYX

Product NDC
0069-6001
11-digit product format
000696001
Labeler code
0069
Product ID
0069-6001_c2767f24-e5ac-4d94-8bff-faf0a6eaf7c4
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
0069-6001-02CEREBYX2 mL in 1 VIALINJECTION, SOLUTION238
0069-6001-10CEREBYX10 mL in 1 VIALINJECTION, SOLUTION1038
0069-6001-21CEREBYX10 in 1 PACKAGEINJECTION, SOLUTION1038
0069-6001-25CEREBYX25 in 1 CARTONINJECTION, SOLUTION2538

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-6001-02ML - Milliliter0069-6001e2a8b28a-6680-4e88-9ce7-4dadab2f124b12013-11-04
0069-6001-10ML - Milliliter0069-60015ad38478-a5db-4b13-8b3f-f1df1b18d1c512013-11-04
0069-6001-21ML - Milliliter0069-6001a97ad0a1-d3a6-4469-9a68-96b7ec5d388e12013-11-04
0069-6001-25ML - Milliliter0069-6001239b26ce-2129-4447-ac3d-98562cdeb49012013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FOSPHENYTOIN SODIUMACTIVE INGREDIENT7VLR55452ZCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]8
PHENYTOINACTIVE MOIETY6158TKW0C5CEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]8
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]8
WATERINACTIVE INGREDIENT059QF0KO0RCEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-6001CEREBYX (FOSPHENYTOIN SODIUM) INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]37Current NDC, Legacy NDC, 4 package rows20240830_d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670201Cerebyx 100 MG PE in 2 ML InjectionPSNd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670197Cerebyx 500 MG PE in 10 ML InjectionPSNd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSNd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSNd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
167019710 ML fosphenytoin sodium 75 MG/ML Injection [Cerebyx]SBDd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
16702012 ML fosphenytoin sodium 75 MG/ML Injection [Cerebyx]SBDd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCDd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCDd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
167019710 ML Cerebyx 75 MG/ML InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
16702012 ML Cerebyx 75 MG/ML InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670201Cerebyx 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670197Cerebyx 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYd4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-6001-02000696001022 mL in 1 VIAL2 mlHistorical
0069-6001-100006960011010 mL in 1 VIAL10 mlHistorical
0069-6001-210006960012110 VIAL in 1 PACKAGE (0069-6001-21) / 10 mL in 1 VIAL (0069-6001-10) 10 vial2013-10-280000-00-00NoNoCurrent
0069-6001-250006960012525 VIAL in 1 CARTON (0069-6001-25) / 2 mL in 1 VIAL (0069-6001-02) 25 vial2013-10-280000-00-00NoNoCurrent