FDA.reportPublic FDA data

Dilantin

Product NDC
0071-0369
11-digit product format
000710369
Labeler code
0071
Product ID
0071-0369_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
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
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
0071-0369-24EA - Each0071-036937c7b18a-67e2-4ba3-ab89-b334d94c64ef12012-07-24
0071-0369-32EA - Each0071-036910de86f8-14b2-48e2-b162-8c2d2a080ed312012-07-24
0071-0369-40EA - Each0071-0369177acda5-8290-4af7-b2b7-2a68130466bc12012-07-24

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
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]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
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]2
Phenytoin SodiumACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
PhenytoinACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
D&C red No. 28INACTIVE INGREDIENT767IP0Y5NHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
sucroseINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
talcINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0071-0369DILANTIN (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
855673Dilantin 100 MG Extended Release Oral CapsulePSNf5b7e576-49b1-4633-ab0a-6ab94922e97011
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNf5b7e576-49b1-4633-ab0a-6ab94922e97011
855673phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]SBDf5b7e576-49b1-4633-ab0a-6ab94922e97011
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDf5b7e576-49b1-4633-ab0a-6ab94922e97011
855673Dilantin 100 MG Extended Release Oral CapsuleSYf5b7e576-49b1-4633-ab0a-6ab94922e97011
855671DPH sodium 100 MG Extended Release Oral CapsuleSYf5b7e576-49b1-4633-ab0a-6ab94922e97011
855673DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]SYf5b7e576-49b1-4633-ab0a-6ab94922e97011
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
855673Dilantin 100 MG Extended Release Oral CapsulePSNecab970d-83e9-4aad-92de-dbb73d7a151f1
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNecab970d-83e9-4aad-92de-dbb73d7a151f1
855673phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]SBDecab970d-83e9-4aad-92de-dbb73d7a151f1
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDecab970d-83e9-4aad-92de-dbb73d7a151f1
855673Dilantin 100 MG Extended Release Oral CapsuleSYecab970d-83e9-4aad-92de-dbb73d7a151f1
855671DPH sodium 100 MG Extended Release Oral CapsuleSYecab970d-83e9-4aad-92de-dbb73d7a151f1
855673DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]SYecab970d-83e9-4aad-92de-dbb73d7a151f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0071-0369-2400071036924100 CAPSULE in 1 BOTTLE (0071-0369-24) 100 capsule1976-08-270000-00-00NoNoCurrent
0071-0369-32000710369321000 CAPSULE in 1 BOTTLE (0071-0369-32) 1000 capsule1976-08-270000-00-00NoNoCurrent
0071-0369-4000071036940100 BLISTER PACK in 1 CARTON (0071-0369-40) > 1 CAPSULE in 1 BLISTER PACK100 blister pack1976-08-270000-00-00NoNoCurrent