FOSPHENYTOIN SODIUM

Product NDC
64679-730
11-digit product format
646790730
Labeler code
64679
Product ID
64679-730_f0f36bc4-c2d6-f525-e053-2995a90adfac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fosphenytoin sodium
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Wockhardt USA LLC.
Application
ANDA078137
Marketing category
ANDA
Marketing start
2007-08-06
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64679-730-01ML - Milliliter64679-730b0fb0072-9804-440b-8a7e-cf4eef80100b12018-03-08
64679-730-02ML - Milliliter64679-7308dc6d3cc-39bd-4d55-83fb-9128909468d412018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-730-016467907300110 VIAL in 1 CARTON (64679-730-01) > 10 mL in 1 VIAL (64679-730-02) 10 vial2007-08-060000-00-00NoNoCurrent