Extended Phenytoin Sodium

Product NDC

70518-0231

11-digit product format

705180231

Labeler code

70518

Product ID

70518-0231_8313556f-2cf3-0ed0-e053-2991aa0a79de

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Phenytoin Sodium

Dosage form

CAPSULE

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA040765

Marketing category

ANDA

Marketing start

2017-02-16

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

2020-12-31

Current FDA listing

Historical FDA.report record