Dilantin (Page 7 of 7)

PRINCIPAL DISPLAY PANEL — 30 mg Capsule Bottle Label

ALWAYS DISPENSE WITH ACCOMPANYING MEDICATION GUIDE

Pfizer

NDC 0071-3740-66

Dilantin ^®

(extended phenytoinsodium capsules, USP)

30 mg

100 Capsules

Rx only

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Bottle Label

ALWAYS DISPENSE WITH ACCOMPANYING MEDICATION GUIDE

Pfizer

NDC 0071-0369-24

Dilantin ^®

(extended phenytoinsodium capsules, USP)

100 mg

100 Capsules

Rx only

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Blister Pack

Dilantin ^®
(phenytoin sodium)
Extended Oral Capsule

100 mg

Protect From
Light and Moisture.
DIST BY PARKE-DAVISDIV OF PFIZER INC, NY, NY 10017

LOT AREA & EXP

PRINCIPAL DISPLAY PANEL — 100 mg Capsule Blister Pack Carton

UNIT DOSE

ALWAYS DISPENSE WITH ACCOMPANYING MEDICATION GUIDE

Pfizer

NDC 0071-0369-40

Dilantin ^® (extended phenytoin sodium capsules, USP)

100 mg

For in-institution use only

100 Capsules

Rx only

DILANTIN extended phenytoin sodium capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0071-3740 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 30 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE SUCROSE TALC MAGNESIUM STEARATE TITANIUM DIOXIDE GELATIN, UNSPECIFIED D&C YELLOW NO. 10 FD&C RED NO. 3

Product Characteristics Color WHITE (opaque) , PINK (pale pink opaque) Score no score Shape CAPSULE Size 14mm Flavor Imprint Code PD;Dilantin;30;mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0071-3740-66 100 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084349 08/27/1976

DILANTIN extended phenytoin sodium capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0071-0369 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 100 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE SUCROSE TALC MAGNESIUM STEARATE TITANIUM DIOXIDE GELATIN, UNSPECIFIED D&C RED NO. 28 FD&C YELLOW NO. 6

Product Characteristics Color WHITE (opaque) , ORANGE (medium orange) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code PD;DILANTIN;100;mg Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0071-0369-24 100 CAPSULE in 1 BOTTLE None 2 NDC:0071-0369-32 1000 CAPSULE in 1 BOTTLE None 3 NDC:0071-0369-40 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK 3 1 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (0071-0369-40)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA084349 08/27/1976

Labeler — Parke-Davis Div of Pfizer Inc (829076962)

Registrant — Pfizer Inc (113480771)

Establishment
Name	Address	ID/FEI	Operations
Pharmacia & Upjohn Company LLC		618054084	ANALYSIS (0071-0369), ANALYSIS (0071-3740), API MANUFACTURE (0071-0369), API MANUFACTURE (0071-3740)

Establishment
Name	Address	ID/FEI	Operations
Pfizer Pharmaceuticals LLC		829084552	ANALYSIS (0071-0369), ANALYSIS (0071-3740), MANUFACTURE (0071-0369), MANUFACTURE (0071-3740), PACK (0071-0369), PACK (0071-3740), LABEL (0071-0369), LABEL (0071-3740)

Revised: 03/2022 Parke-Davis Div of Pfizer Inc