Phenytoin Sodium
Extended Phenytoin Sodium Capsules USP, 100 mg
Approved
Approval ID
6794195c-47fa-47e9-9bac-cbbbdfbeef68
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 12, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenytoin Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5534
Application NumberANDA040684
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin Sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2012
FDA Product Classification
INGREDIENTS (17)
Phenytoin SodiumActive
Quantity: 100 mg in 1 1
Code: 4182431BJH
Classification: ACTIB
lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
butylparabenInactive
Code: 3QPI1U3FV8
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
sodium propionateInactive
Code: DK6Y9P42IN
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
edetate calcium disodiumInactive
Code: 25IH6R4SGF
Classification: IACT
FD&C Red NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT