Regonol (Page 3 of 3)

Carton

NDC 0781-3040-95

Regonol® Contains Benzyl Alcohol. Not for use in neonates.

(Pyridostigmine Bromide Injection, USP)

10 mg/2 mL (5 mg/mL)

FOR INTRAVENOUS USE ONLY

Rx only

Sterile

10 x 2 mL Single-Dose Ampules

SANDOZ – A Novartis Division

carton
(click image for full-size original)
REGONOL
pyridostigmine bromide injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0781-3040
Route of Administration INTRAVENOUS, PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE) PYRIDOSTIGMINE BROMIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CITRIC ACID MONOHYDRATE
SODIUM CITRATE, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-3040-95 10 AMPULE in 1 CARTON contains a AMPULE (0781-3040-72)
1 NDC:0781-3040-72 2 mL in 1 AMPULE This package is contained within the CARTON (0781-3040-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017398 05/10/2005
Labeler — Sandoz Inc (005387188)

Revised: 04/2021 Sandoz Inc

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