NDC Code(s) : 63323-143-97
Packager : Fresenius Kabi USA, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Addamel NCHROMIUM, COPPER, IRON, MANGANESE, IODINE, FLUORINE, MOLYBDENUM, SELENIUM, and ZINC INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-143
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHROMIC CHLORIDE(UNII: KB1PCR9DMW)
(CHROMIC CATION - UNII:X1N4508KF1) 		CHROMIC CATION1 ug in 1 mL
CUPROUS CHLORIDE(UNII: C955P95064)
(CUPRIC CATION - UNII:8CBV67279L) 		CUPRIC CATION0.13 mg in 1 mL
FERRIC CHLORIDE(UNII: U38V3ZVV3V)
(FERRIC CATION - UNII:91O4LML611) 		FERRIC CATION0.11 mg in 1 mL
MANGANESE CHLORIDE(UNII: QQE170PANO)
(MANGANESE CATION (2+) - UNII:H6EP7W5457) 		MANGANESE CATION (2+)0.027 mg in 1 mL
POTASSIUM IODIDE(UNII: 1C4QK22F9J)
(IODIDE ION - UNII:09G4I6V86Q) 		POTASSIUM IODIDE0.013 mg in 1 mL
SODIUM FLUORIDE(UNII: 8ZYQ1474W7)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION0.095 mg in 1 mL
SODIUM MOLYBDATE DIHYDRATE(UNII: 8F2SXI1704)
(MOLYBDATE ION - UNII:O0L10E6352) 		MOLYBDATE ION1.9 ug in 1 mL
SODIUM SELENITE(UNII: HIW548RQ3W)
(SELENITE ION - UNII:KXO0259XJ1) 		SELENITE ION3.2 ug in 1 mL
ZINC CHLORIDE(UNII: 86Q357L16B)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION0.65 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM(UNII: 9NEZ333N27)5.12 umol in 1 mL
POTASSIUM(UNII: RWP5GA015D)0.1 umol in 1 mL
HYDROCHLORIC ACID(UNII: QTT17582CB)
XYLITOL(UNII: VCQ006KQ1E)300 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63323-143-9720 in 1 CARTON
110 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 05/07/2013

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Addamel™ N 10 mL Ampule Label

10 ml

Addamel™ N

Concentrate for infusion

 

vial-lya1941 

 

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Addamel™ N 10 mL Carton Panel

20 ampoules of 20 ml

Addamel™ N

Concentrate for infusion


vial-lya1941