Fosphenytoin Sodium (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

NDC 0641-6136 -01 Rx only
Fosphenytoin
Sodium Injection, USP
100 mg PE per 2 mL
(50 mg PE/mL)
(PE = phenytoin
sodium equivalents)
For IM or IV use2 mL Vial

vial
(click image for full-size original)

NDC 0641-6136 -25 Rx only
Fosphenytoin
Sodium Injection, USP
100 mg PE per 2 mL
(50 mg PE/mL)
(PE = phenytoin sodium equivalents)
For IM or IV use
25 x 2 mL Single Dose Vials

sp
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0641-6137 -01 Rx only
Fosphenytoin
Sodium Injection, USP
500 mg PE per 10 mL
(50 mg PE/mL)
(PE = phenytoin sodium equivalents)
For IM or IV use
10 mL Vial

vial
(click image for full-size original)

NDC 0641-6137 -10 Rx only
Fosphenytoin
Sodium Injection, USP
500 mg PE in 10 mL
(50 m
g PE/mL)
(PE = phenytoin sodium equivalents)
For IM or IV use 10 x 10 mL Single Dose Vials

sp
(click image for full-size original)

SERIALIZATION IMAGE

Layout 1

FOSPHENYTOIN SODIUM fosphenytoin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6136
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSPHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6136-25 25 VIAL in 1 CARTON contains a VIAL (0641-6136-01)
1 NDC:0641-6136-01 2 mL in 1 VIAL This package is contained within the CARTON (0641-6136-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077989 08/06/2007
FOSPHENYTOIN SODIUM fosphenytoin sodium injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0641-6137
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOSPHENYTOIN SODIUM (PHENYTOIN) PHENYTOIN SODIUM 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TROMETHAMINE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0641-6137-10 10 VIAL in 1 CARTON contains a VIAL (0641-6137-01)
1 NDC:0641-6137-01 10 mL in 1 VIAL This package is contained within the CARTON (0641-6137-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077989 08/06/2007
Labeler — Hikma Pharmaceuticals USA Inc. (946499746)
Establishment
Name Address ID/FEI Operations
Hikma Pharmaceuticals USA Inc. 946499746 analysis (0641-6136), analysis (0641-6137), label (0641-6136), label (0641-6137), manufacture (0641-6136), manufacture (0641-6137)

Revised: 01/2022 Hikma Pharmaceuticals USA Inc.

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