Phenytoin

Product NDC
60432-131
11-digit product format
604320131
Labeler code
60432
Product ID
60432-131_fe641407-3c6d-4f41-9cd9-c821256bb22b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA040420
Marketing category
ANDA
Marketing start
2002-06-24
Marketing end
0000-00-00
Substance
PHENYTOIN
Active strength
125 mg/5mL
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-131-08ML - Milliliter60432-13134176b38-5caa-4460-b5ef-2634afd0ab4b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
AlcoholINACTIVE INGREDIENT3K9958V90MPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
polysorbate 40INACTIVE INGREDIENTSTI11B5A2XPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
raw sugarINACTIVE INGREDIENT8M707QY5GHPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
vanillinINACTIVE INGREDIENTCHI530446XPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
waterINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [ATLANTIC BIOLOGICALS CORPS]2
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
polysorbate 40INACTIVE INGREDIENTSTI11B5A2XPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
raw sugarINACTIVE INGREDIENT8M707QY5GHPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
vanillinINACTIVE INGREDIENTCHI530446XPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN25acb26b-04ef-4589-8955-71d777dc813d2
1313112phenytoin 25 MG/ML Oral SuspensionSCD25acb26b-04ef-4589-8955-71d777dc813d2
1313112DPH 25 MG/ML Oral SuspensionSY25acb26b-04ef-4589-8955-71d777dc813d2
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY25acb26b-04ef-4589-8955-71d777dc813d2
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY25acb26b-04ef-4589-8955-71d777dc813d2
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN9ce9adc8-6fa2-4444-8386-14cd576ac63d1
1313112phenytoin 25 MG/ML Oral SuspensionSCD9ce9adc8-6fa2-4444-8386-14cd576ac63d1
1313112DPH 25 MG/ML Oral SuspensionSY9ce9adc8-6fa2-4444-8386-14cd576ac63d1
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY9ce9adc8-6fa2-4444-8386-14cd576ac63d1
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY9ce9adc8-6fa2-4444-8386-14cd576ac63d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-131-0860432013108237 mL in 1 BOTTLE, GLASS (60432-131-08) 237 ml2002-06-240000-00-00NoNoCurrent