EXTENDED PHENYTOIN SODIUM

Product NDC

55289-906

11-digit product format

552890906

Labeler code

55289

Product ID

55289-906_7c3433f5-f826-6e4b-e053-2a91aa0a5056

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

EXTENDED PHENYTOIN SODIUM

Dosage form

CAPSULE

Route

ORAL

Labeler

PD-Rx Pharmaceuticals, Inc.

Application

ANDA040732

Marketing category

ANDA

Marketing start

2008-01-30

Marketing end

0000-00-00

Substance

PHENYTOIN SODIUM

Active strength

100 mg/1

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

2019-12-31

Current FDA listing

Historical FDA.report record