NDC Code(s) : 76451-013-10
Packager : 3D Imaging Drug Design and Development LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ammonia AMMONIA N-13 INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76451-013
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMMONIA N-13(UNII: 9OQO0E343Z)
(AMMONIA N-13 - UNII:9OQO0E343Z) 		AMMONIA N-1337.5 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE(UNII: 451W47IQ8X)9 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76451-013-1010 mL in 1 VIAL, GLASS Type 0: Not a Combination Product17/12/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203779 01/02/2012

LABELER - 3D Imaging Drug Design and Development LLC(802267471)

Establishment
Name Address ID/FEI Business Operations
3D Imaging Drug Design and Development LLC 802267471 positron emission tomography drug production(76451-013)

PRINCIPAL DISPLAY PANEL

Outer labels are exterior to the radiation shielding for the product vial and contain the direct labeling information. There is an inner label that can be printed and applied in advance to avoid radiation dose to the operators and is small enough to affix to the vial. The inner label contains the product name and a batch number that positively connects it to the correct outer label. The outer label contains complete package label information and all dose information that is determined at the time of filling.