Phenytoin
PHENYTOIN ORAL SUSPENSION, USP (Not for Parenteral Use)
Approved
Approval ID
9ce9adc8-6fa2-4444-8386-14cd576ac63d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 1, 2009
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2038
Application NumberANDA040420
Product Classification
M
Marketing Category
C73584
G
Generic Name
Phenytoin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 10, 2011
FDA Product Classification
INGREDIENTS (15)
magnesium aluminum silicateInactive
Code: 6M3P64V0NC
Classification: IACT
carboxymethylcellulose sodiumInactive
Code: K679OBS311
Classification: IACT
PhenytoinActive
Quantity: 125 mg in 5 mL
Code: 6158TKW0C5
Classification: ACTIB
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
raw sugarInactive
Code: 8M707QY5GH
Classification: IACT
polysorbate 40Inactive
Code: STI11B5A2X
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
vanillinInactive
Code: CHI530446X
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT