Glycopyrrolate (Page 2 of 2)

HOW SUPPLIED

Glycopyrrolate Tablets, USP 1 mg are white, round, scored, flat-faced, beveled edge, debossed “3180″ on one side and debossed “V” on the reverse side, supplied in bottles of 10, 100, and 1000.

Glycopyrrolate Tablets, USP 2 mg are white, round, scored, flat-faced, beveled edge, debossed “3181″ on one side and debossed “V” on the reverse side, supplied in bottles of 10, 100, and 1000.

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

Dispense in tight container.

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8182341
R12/08-R0

PRINCIPAL DISPLAY PANEL

This is an image of the Principal Display Panel for Glycopyrrolate 1 mg 100 Tablets.
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

This is an image of the Principal Display Panel for Glycopyrrolate 2 mg 100 Tablets.
(click image for full-size original)
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3180
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 1 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 7mm
Flavor Imprint Code 3180;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-3180-10 10 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0603-3180-21 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:0603-3180-32 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040821 12/29/2008 05/31/2017
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-3181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GLYCOPYRROLATE (GLYCOPYRRONIUM) GLYCOPYRROLATE 2 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 3181;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0603-3181-10 10 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:0603-3181-21 100 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:0603-3181-32 1000 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040821 12/29/2008 06/30/2017
Labeler — Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE (0603-3180), MANUFACTURE (0603-3181)

Revised: 10/2015 Qualitest Pharmaceuticals

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2019. All Rights Reserved.