Prescription Drug Information: Glycopyrrolate (Page 3 of 3)

PEPTIC ULCER

Glycopyrrolate injection is not recommended for the treatment of peptic ulcer in pediatric patients ( see PRECAUTIONS — Pediatric Use) .

Diluent Compatibilities

Dextrose 5% and 10% in water, or saline, dextrose 5% in sodium chloride 0.45%, sodium chloride 0.9%, and Ringer’s Injection.

Diluent Incompatibilities

Lactated Ringer’s solution

Admixture Compatibilities

PHYSICAL COMPATIBILITY

This list does not constitute an endorsement of the clinical utility or safety of co-administration of glycopyrrolate with these drugs. Glycopyrrolate injection is compatible for mixing and injection with the following injectable dosage forms: atropine sulfate, USP; Antilirium® (physostigmine salicylate); Benadryl® (diphenhydramine HCl); codeine phosphate, USP; Emete-Con® (benzquinamide HCl); hydromorphone HCl, USP; Inapsine® (droperidol); Levo-Dromoran® (levorphanol tartrate); lidocaine, USP; meperidine HCl, USP; Mestinon® /Regonol® (pyridostigmine bromide); morphine sulfate, USP; Nubain® (nalbuphine HCl); Numorphan® (oxymorphone HCl); procaine HCl, USP; promethazine HCl, USP; Prostigmin® (neostigmine methylsulfate, USP); scopolamine HBr, USP; Stadol® (butorphanol tartrate); Sublimaze® (fentanyl citrate); Tigan® (trimethobenzamide HCl); and Vistaril® (hydroxyzine HCl). Glycopyrrolate injection may be administered via the tubing of a running infusion of normal saline.

Admixture Incompatibilities

PHYSICAL INCOMPATIBILITY

Since the stability of glycopyrrolate is questionable above a pH of 6.0 do not combine glycopyrrolate injection in the same syringe with Brevital® (methohexital Na); Chloromycetin® (chloramphenicol Na succinate); Dramamine® (dimenhydrinate); Nembutal® (pentobarbital Na); Pentothal® (thiopental Na); Seconal® (secobarbital Na); sodium bicarbonate (Abbott); Valium® (diazepam); Decadron® (dexamethasone Na phosphate); or Talwin® (pentazocine lactate). These mixtures will result in a pH higher than 6.0 and may result in gas production or precipitation.

HOW SUPPLIED

Glycopyrrolate injection, USP, 0.2 mg/mL, is available in:

1 mL single dose vials (NDC 16714-536-01) packaged in 25s (NDC 16714-536-25)
2 mL single dose vials (NDC 16714-620-01) packaged in 25s (NDC 16714-620-25)

Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821, or the FDA at 1-800‑FDA‑1088 or www.fda.gov/medwatch.

All registered trademarks in this document are the property of their respective owners.

Manufactured by: Manufactured for:
Indoco Remedies Limited L-32, 33, 34, Verna Industrial Area, Verna, Goa-403722, India Northstar Rx LLCMemphis, TN 38141

Revised: April 2022

NDC 16714-536-01

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.2 mg/1 mL (0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV USE
Vial Label
1 mL Single Dose Vial Rx Only

//rxdruglabels.com/lib/images-rx/glycopyrrolate-17/1-ml-vial-label-300x101.jpg
(click image for full-size original)

NDC 16714-536-25

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.2mg/1 mL
(0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV Administration
Carton Label
25 x 1 mL Single Dose Vials
Rx Only

//rxdruglabels.com/lib/images-rx/glycopyrrolate-17/1-ml-carton-label-300x176.jpg
(click image for full-size original)

NDC 16714-620-01

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.4 mg/2 mL (0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV USE
Vial Label
2 mL Single Dose Vial Rx Only

//rxdruglabels.com/lib/images-rx/glycopyrrolate-17/2-ml-vial-label-300x99.jpg
(click image for full-size original)

NDC 16714-620-25

Northstar Rx LLC
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
CONTAINS BENZYL ALCOHOL
FOR IM OR IV Administration
Carton Label
25 x 2 mL Single Dose Vials Rx Only

//rxdruglabels.com/lib/images-rx/glycopyrrolate-17/2-ml-carton-label-300x177.jpg
(click image for full-size original)
GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-536
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-536-25 25 VIAL in 1 CARTON contains a VIAL
1 1 mL in 1 VIAL This package is contained within the CARTON (16714-536-25)
2 NDC:16714-536-01 1 VIAL in 1 CARTON contains a VIAL
2 1 mL in 1 VIAL This package is contained within the CARTON (16714-536-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210246 08/10/2022
GLYCOPYRROLATE glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-620
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
BENZYL ALCOHOL 9 mg in 1 mL
HYDROCHLORIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-620-25 25 VIAL in 1 CARTON contains a VIAL
1 2 mL in 1 VIAL This package is contained within the CARTON (16714-620-25)
2 NDC:16714-620-01 1 VIAL in 1 CARTON contains a VIAL
2 2 mL in 1 VIAL This package is contained within the CARTON (16714-620-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210246 11/18/2022
Labeler — NORTHSTAR RX LLC (830546433)
Registrant — Apotex Inc. (209429182)

Revised: 11/2022 NORTHSTAR RX LLC

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