Phenytoin Sodium

Product NDC
51079-905
11-digit product format
510790905
Labeler code
51079
Product ID
51079-905_e16f10ad-cde9-591e-e053-2995a90a2b6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA040298
Marketing category
ANDA
Marketing start
1999-05-01
Marketing end
2023-02-28
Substance
PHENYTOIN SODIUM
Active strength
100 mg/1
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-905-01EA - Each51079-9059f2e4935-2fd5-4b5b-979e-c59f1d2c0d0a12013-02-13
51079-905-17EA - Each51079-9050542110f-30ae-4fe4-86df-d155eaa3f4ac12013-02-13
51079-905-19EA - Each51079-905672787c6-8af5-4dde-b623-1c109f18ee1012013-02-13
51079-905-20EA - Each51079-905810e26b0-89ec-4ebf-8f59-f9c7b6faee7312013-02-13
51079-905-30EA - Each51079-905ec052ee2-e856-4492-8e13-05c9ac74f19112015-12-02
51079-905-56EA - Each51079-905800d5c7c-bb3a-4041-a145-f4a704998dbe12013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-905-2051079090520100 BLISTER PACK in 1 CARTON (51079-905-20) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (51079-905-01) 100 blister pack1999-05-010000-00-00NoNoCurrent