Papaverine Hydrochloride (Page 2 of 2)

DOSAGE AND ADMINISTRATION

Papaverine Hydrochloride may be administered intravenously or intramuscularly. The intravenous route is recommended when an immediate effect is desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid uncomfortable or alarming side effects.

Parenteral administration of papaverine hydrochloride in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment of cardiac extrasystoles, 2 doses may be given 10 minutes apart.

HOW SUPPLIED:

Papaverine Hydrochloride Injection, USP, 30 mg/mL

NDC: 14789-121-07 2 mL Single-dose Vial

NDC: 14789-121-05 10 pack carton of 2 mL Single-dose Vials

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).

PROTECT FROM LIGHT. RETAIN IN CARTON UNTIL TIME OF USE.

Manufactured for:

Nexus Pharmaceuticals, Inc. Lincolnshire, IL 60069

PAPPIR001 Revised 02/2021

Made in Germany

NEXUS
PHARMACEUTICALS

Principal Display Panel – 2 mL Carton Label

NDC 14789-121-05

Rx Only

PAPAVERINE HYDROCHLORIDE
INJECTION, USP

60mg/2mL
(30 mg/mL)

10 x 2mL Single-dose Vials

NEXUS
PHARMACEUTICALS

Principal Display Panel – 2 mL Carton Label
(click image for full-size original)

Principal Display Panel – 2 mL Vial Label

NDC 14789-121-07

Rx Only

PAPAVERINE HYDROCHLORIDE
INJECTION, USP

60mg/2mL (30 mg/mL)

2mL Single-dose Vials

Made in Germany

NEXUS
PHARMACEUTICALS

Principal Display Panel – 2 mL Vial Label
(click image for full-size original)
PAPAVERINE HYDROCHLORIDE
papaverine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:14789-121
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Papaverine Hydrochloride (Papaverine) Papaverine Hydrochloride 30 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Edetate Disodium 0.05 mg in 1 mL
Sodium Citrate
Citric Acid Monohydrate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14789-121-05 10 VIAL, SINGLE-USE in 1 CARTON contains a VIAL, SINGLE-USE (14789-121-07)
1 NDC:14789-121-07 2 mL in 1 VIAL, SINGLE-USE This package is contained within the CARTON (14789-121-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/28/2021
Labeler — Nexus Pharmaceuticals Inc (620714787)
Establishment
Name Address ID/FEI Operations
Nexus Pharmaceuticals Inc 620714787 ANALYSIS (14789-121)

Revised: 04/2021 Nexus Pharmaceuticals Inc

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