FDA.reportPublic FDA data

Fosphenytoin Sodium

Product NDC
25021-798
11-digit product format
250210798
Labeler code
25021
Product ID
25021-798_20212ecb-248d-4fc6-b88d-c54a18076845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fosphenytoin Sodium
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA214926
Marketing category
ANDA
Marketing start
2025-01-15
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
Fosphenytoin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FOSPHENYTOIN SODIUM50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7VLR55452Z
Rxcui1670195, 1670200

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
25021-798-02Fosphenytoin Sodium2 mL in 1 VIALINJECTION, SOLUTION21
25021-798-02Fosphenytoin Sodium25 in 1 CARTONINJECTION, SOLUTION251
25021-798-10Fosphenytoin Sodium10 mL in 1 VIALINJECTION, SOLUTION101
25021-798-10Fosphenytoin Sodium10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-798-02ML - Milliliter25021-7980e873638-9a72-4873-934f-6f7f783664ef12025-03-04
25021-798-10ML - Milliliter25021-798f5fba415-ba4c-4073-b67a-e3605a56350e12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-798FOSPHENYTOIN SODIUM INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 4 package rows20250115_e1dab8ad-cbf6-4273-92fa-02629de2abde.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1670200fosphenytoin sodium 150 MG (as PE 100 MG) per 2 ML InjectionPSNe1dab8ad-cbf6-4273-92fa-02629de2abde1
1670195fosphenytoin sodium 750 MG (as PE 500 MG) per 10 ML InjectionPSNe1dab8ad-cbf6-4273-92fa-02629de2abde1
167019510 ML fosphenytoin sodium 75 MG/ML InjectionSCDe1dab8ad-cbf6-4273-92fa-02629de2abde1
16702002 ML fosphenytoin sodium 75 MG/ML InjectionSCDe1dab8ad-cbf6-4273-92fa-02629de2abde1
1670200fosphenytoin sodium 100 MG PE per 2 ML InjectionSYe1dab8ad-cbf6-4273-92fa-02629de2abde1
1670195fosphenytoin sodium 500 MG PE per 10 ML InjectionSYe1dab8ad-cbf6-4273-92fa-02629de2abde1
1670200fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 100 MG per 2 ML) InjectionSYe1dab8ad-cbf6-4273-92fa-02629de2abde1
1670195fosphenytoin sodium 75 MG/ML (as phenytoin sodium equivalents 500 MG per 10 ML) InjectionSYe1dab8ad-cbf6-4273-92fa-02629de2abde1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-798-022502107980225 VIAL in 1 CARTON (25021-798-02) / 2 mL in 1 VIAL25 vial2025-01-15NoNoCurrent
25021-798-102502107981010 VIAL in 1 CARTON (25021-798-10) / 10 mL in 1 VIAL10 vial2025-01-15NoNoCurrent