Prescription Drug Information: GLYCOPYRROLATE (Page 3 of 3)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43547-639-25

Glycopyrrolate Injection, USP

0.2 mg/mL RX only

FOR IM OR IV ADMINISTRATION

25 X 1 mL Single Dose Vials

Water for Injection, USP q.s.

pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.

USUAL DOSAGE:

See package insert.

Store at 20°C to 25°C (68°F to 77°F)[See USP Controlled Room Temperature].

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

0.2 mg/ml
(click image for full-size original)

NDC 43547-640-25

Glycopyrrolate Injection, USP

0.4 mg/2 mL (0.2 mg/mL) RX only

FOR IM OR IV ADMINISTRATION

25 X 2 mL Single Dose Vials

Water for Injection, USP q.s.

pH adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide.

USUAL DOSAGE:

See package insert.

Store at 20°C to 25°C (68°F to 77°F)[See USP Controlled Room Temperature].

Distributed by:

Solco Healthcare US, LLC

Somerset, NJ 08873, USA

0.4 mg/ 2 ml
(click image for full-size original)
GLYCOPYRROLATE
glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-639
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
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43547-639-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43547-639-01)
1 NDC:43547-639-01 1 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43547-639-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210927 03/20/2019
GLYCOPYRROLATE
glycopyrrolate injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43547-640
Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 0.4 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43547-640-25 25 VIAL, SINGLE-DOSE in 1 CARTON contains a VIAL, SINGLE-DOSE (43547-640-01)
1 NDC:43547-640-01 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the CARTON (43547-640-25)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210927 03/20/2019
Labeler — Solco Healthcare US, LLC (828343017)

Revised: 05/2021 Solco Healthcare US, LLC

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