FDA.reportPublic FDA data

Dilantin

Product NDC
0071-3740
11-digit product format
000713740
Labeler code
0071
Product ID
0071-3740_06311c9f-47af-4aae-a7a4-a0a40182ee7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Extended Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Parke-Davis Div of Pfizer Inc
Application
ANDA084349
Marketing category
ANDA
Marketing start
1976-08-27
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
30 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
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
0071-3740-66EA - Each0071-3740d2a56e7e-4f9f-4f0a-b177-346aa20c364812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PARKE-DAVIS DIV OF PFIZER INC]24
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0071-3740DILANTIN (EXTENDED PHENYTOIN SODIUM) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]56Legacy NDC20250410_8848de76-8d74-4620-bcc7-a86a596e5dd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855871Dilantin 30 MG Extended Release Oral CapsulePSN4f918d15-908e-4c3a-94d6-71370da9a1164
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSN4f918d15-908e-4c3a-94d6-71370da9a1164
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBD4f918d15-908e-4c3a-94d6-71370da9a1164
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCD4f918d15-908e-4c3a-94d6-71370da9a1164
855871Dilantin 30 MG Extended Release Oral CapsuleSY4f918d15-908e-4c3a-94d6-71370da9a1164
855869DPH sodium 30 MG Extended Release Oral CapsuleSY4f918d15-908e-4c3a-94d6-71370da9a1164
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SY4f918d15-908e-4c3a-94d6-71370da9a1164
855673Dilantin 100 MG Extended Release Oral CapsulePSN1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855871Dilantin 30 MG Extended Release Oral CapsulePSN1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSN1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855673phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]SBD1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBD1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCD1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855673Dilantin 100 MG Extended Release Oral CapsuleSY1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855871Dilantin 30 MG Extended Release Oral CapsuleSY1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855671DPH sodium 100 MG Extended Release Oral CapsuleSY1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855673DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]SY1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855869DPH sodium 30 MG Extended Release Oral CapsuleSY1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SY1fd75c5a-f56b-42a2-aa4a-9cd0344d0a6f2
855871Dilantin 30 MG Extended Release Oral CapsulePSN5554a280-0490-4235-9c8c-bea141db68841
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSN5554a280-0490-4235-9c8c-bea141db68841
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBD5554a280-0490-4235-9c8c-bea141db68841
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCD5554a280-0490-4235-9c8c-bea141db68841
855871Dilantin 30 MG Extended Release Oral CapsuleSY5554a280-0490-4235-9c8c-bea141db68841
855869DPH sodium 30 MG Extended Release Oral CapsuleSY5554a280-0490-4235-9c8c-bea141db68841
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SY5554a280-0490-4235-9c8c-bea141db68841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-3740-6600071374066100 CAPSULE in 1 BOTTLE (0071-3740-66) 100 capsule1976-08-270000-00-00NoNoCurrent