Nitroglycerin (Page 4 of 4)

HOW SUPPLIED:

Nitroglycerin Injection, USP, 5 mg/mL is available as follows:

NDC 0517-4810-25

50 mg/10 mL Single Dose Vial

Packages of 25

PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
DISCARD UNUSED PORTION.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN4805
Rev. 11/05
MG #6925

PRINCIPAL DISPLAY PANEL — 10 mL Container

NDC 0517-4810-01

NITROGLYCERIN INJECTION, USP

50 mg/10 mL (5 mg/mL)

10 mL SINGLE DOSE VIAL

NOT FOR DIRECT IV INJECTION. FOR IV INFUSION ONLY.

MUST BE DILUTED BEFORE USE.

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

PRINCIPAL DISPLAY PANEL — 10 mL Carton

NDC 0517-4810-25

NITROGLYCERIN INJECTION, USP

50 mg/10 mL (5 mg/mL)

25 x 10 mL SINGLE DOSE VIALS

Rx Only

NOT FOR DIRECT INTRAVENOUS INJECTION. FOR INTRAVENOUS INFUSION ONLY. MUST BE DILUTED BEFORE USE. ONLY GLASS INTRAVENOUS BOTTLES SHOULD BE USED IN PREPARING THE INTRAVENOUS ADMIXTURE (SEE INSERT).

Each mL contains: Nitroglycerin 5 mg, Alcohol 30% (v/v), Propylene Glycol 30%, Water for Injection q.s. pH (range 3.0 – 6.5) adjusted with Sodium Hydroxide and/or Hydrochloric Acid. Sterile. PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE. Store at 20° — 25°C (68° — 77°F); excursions permitted to 15° — 30°C (59° — 86°) (See USP Controlled Room Temperature). DISCARD UNUSED PORTION.

Directions for Use: See Package Insert.

AMERICAN REGENT, INC.

SHIRLEY, NY 11967

Serialization Label

NITROGLYCERIN nitroglycerin injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 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

Inactive Ingredients Ingredient Name Strength ALCOHOL PROPYLENE GLYCOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0517-4810-25 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (0517-4810-01) 1 NDC:0517-4810-01 10 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (0517-4810-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA072034 03/04/2003

Labeler — American Regent, Inc. (002033710)

Establishment
Name	Address	ID/FEI	Operations
American Regent, Inc.		002033710	analysis (0517-4810), manufacture (0517-4810)

Revised: 07/2021 American Regent, Inc.