Phenytoin

Product NDC
17856-4069
11-digit product format
178564069
Labeler code
17856
Product ID
17856-4069_72a45cbd-e2e7-4804-b314-813fe1b64d58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA040521
Marketing category
ANDA
Marketing start
2004-04-08
Marketing end
0000-00-00
Substance
PHENYTOIN
Active strength
125 mg/5mL
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 1A2 Inducers [MoA],Cytochrome P450 2B6 Inducers [MoA],Cytochrome P450 2C8 Inducers [MoA],Cytochrome P450 2C19 Inducers [MoA],Cytochrome P450 2D6 Inducers [MoA],Cytochrome P450 3A Inducers [MoA],Cytochrome P450 2C9 Inducers [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-4069-4ML - Milliliter17856-4069a5e49d3a-8c2b-4491-a439-bc47dbf5ebac12014-07-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-4069-4178564069044.8 mL in 1 CUP (17856-4069-4) 4.8 ml2021-01-250000-00-00NoNoCurrent