NDC Code(s) : 55154-5118-5
Packager : Cardinal Health 107, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexamethasone Sodium PhosphateDexamethasone Sodium Phosphate INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5118(NDC:0641-0367)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE SODIUM PHOSPHATE(UNII: AI9376Y64P)
(DEXAMETHASONE - UNII:7S5I7G3JQL) 		DEXAMETHASONE10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM SULFATE ANHYDROUS(UNII: 36KCS0R750)1.5 mg in 1 mL
ANHYDROUS TRISODIUM CITRATE(UNII: RS7A450LGA)16.5 mg in 1 mL
BENZYL ALCOHOL(UNII: LKG8494WBH)10.42 mg in 1 mL
water(UNII: 059QF0KO0R)
sodium hydroxide(UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5118-55 in 1 BAG 09/07/1982
11 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA087702 09/07/1982

LABELER - Cardinal Health 107, LLC(118546603)

PRINCIPAL DISPLAY PANEL

Dexamethasone Sodium Phosphate Injection, USP

10 mg/ml

Dexamethasone Phosphate Equivalent

5 x 1 ml Vials

Bag Label