Nitroglycerin (Page 3 of 3)

How Supplied

Nitroglycerin Injection, USP, 5mg/mL is available as follows:
NDC 0517-4810-25 50mg/10 mL Single Dose Vial Package of 25
PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.
Store at 20°-25°C (68°-77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).DISCARD UNUSED PORTION.

Product repackaged by: Henry Schein, Inc., Bastian, VA 24314
From Original Manufacturer/Distributor’s NDC and Unit of Sale To Henry Schein Repackaged Product NDC and Unit of Sale Total Strength/Total Volume (Concentration) per unit
NDC 0517-4810-25Packages of 25 NDC 0404-9928-101 10 mL Single Dose Vial in a bag(Vial bears NDC 0517-4810-01) 50 mg/10 mL


AMERICAN
REGENT
LABORATORIES, INC.
SHIRLEY, NY 11967
IN4805Rev. 11/05

Sample Package Label

//medlibrary.org/lib/images-rx/nitroglycerin-13/label1-295x300.jpg
(click image for full-size original)

NITROGLYCERIN nitroglycerin injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9928(NDC:0517-4810)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nitroglycerin (Nitroglycerin) Nitroglycerin 5 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0404-9928-10 1 VIAL in 1 BAG contains a VIAL
1 10 mL in 1 VIAL This package is contained within the BAG (0404-9928-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072034 01/13/2022
Labeler — Henry Schein, Inc. (012430880)

Revised: 11/2023 Henry Schein, Inc.

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