NDC Code(s) : 55154-5325-8
Packager : Cardinal Health

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ofirmevacetaminophen INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-5325(NDC:43825-102)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
acetaminophen(UNII: 362O9ITL9D)
(acetaminophen - UNII:362O9ITL9D) 		acetaminophen10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
mannitol(UNII: 3OWL53L36A)
cysteine hydrochloride(UNII: ZT934N0X4W)
sodium phosphate, dibasic(UNII: GR686LBA74)
sodium hydroxide(UNII: 55X04QC32I)
hydrochloric acid(UNII: QTT17582CB)
water(UNII: 059QF0KO0R)
nitrogen(UNII: N762921K75)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-5325-81 in 1 BAG 11/08/2010
1100 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022450 11/08/2010

PRINCIPAL DISPLAY PANEL

OFIRMEV

(Acetaminophen) Injection

1000 mg/100 mL

(10 mg/mL)

1 Vial

bag label