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 -- 30 mg Capsule Bottle Label
(click image for full-size original)

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 Bottle Label
(click image for full-size original)

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
(click image for full-size original)

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

PRINCIPAL DISPLAY PANEL -- 100 mg Capsule Blister Pack Carton
(click image for full-size original)
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: 06/2021 Parke-Davis Div of Pfizer Inc

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.