FOSPHENYTOIN SODIUM

Product NDC
64679-729
11-digit product format
646790729
Labeler code
64679
Product ID
64679-729_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
64679-729-01ML - Milliliter64679-7298f3c1292-6b1c-4973-8870-151fbfc64d3712018-03-08
64679-729-02ML - Milliliter64679-729bf2c1877-deb4-4892-92f3-94c3c8412d2e12018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64679-729-016467907290125 VIAL in 1 CARTON (64679-729-01) > 2 mL in 1 VIAL (64679-729-02) 25 vial2007-08-060000-00-00NoNoCurrent