Glycopyrrolate (Page 2 of 2)

HOW SUPPLIED

Glycopyrrolate tablets, USP 1 mg are white to off-white, round, flat faced, beveled edge, uncoated tablets debossed with ‘RE ’ and ‘28 ’on one side and bisect on the other side. Glycopyrrolate tablets, USP 1 mg are available as

NDC 63304-210-30 Bottles of 30

NDC 63304-210-01 Bottles of 100

NDC 63304-210-10 Bottles of 1000

NDC 63304-210-69 Box of 10 Unit-dose

Glycopyrrolate tablets, USP 2 mg are white to off-white, round, flat faced, beveled edge, uncoated tablets debossed with ‘RE ’ and ‘29 ’on one side and bisect on the other side. Glycopyrrolate tablets, USP 2 mg are available as

NDC 63304-211-30 Bottles of 30

NDC 63304-211-01 Bottles of 100

NDC 63304-211-10 Bottles of 1000

NDC 63304-211-69 Box of 10 Unit-dose

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

Dispense in tight container.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

* Dopram® is a registered trademark of Baxter Healthcare Corporation.

Manufactured for:

Ranbaxy Pharmaceuticals Inc.

Jacksonville, FL 32257 USA

January 2013 FDA-03

PATIENT PACKAGE PRINCIPAL DISPLAY PANEL

This is the 1mg-100s label
(click image for full-size original)

1 mg 100’s bottle label

This is the 2 mg-100s label
(click image for full-size original)

2 mg 100’s bottle label

GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-210
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (flat faced, beveled edge) Size 8mm
Flavor Imprint Code RE28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-210-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:63304-210-01 100 TABLET (TABLET) in 1 BOTTLE None
3 NDC:63304-210-10 1000 TABLET (TABLET) in 1 BOTTLE None
4 NDC:63304-210-69 1 BLISTER PACK (BLISTER) in 1 BOX contains a BLISTER PACK (63304-210-11)
4 NDC:63304-210-11 10 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BOX (63304-210-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040844 08/18/2009
GLYCOPYRROLATE
glycopyrrolate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63304-211
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND (flat faced, beveled edge) Size 10mm
Flavor Imprint Code RE29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63304-211-30 30 TABLET (TABLET) in 1 BOTTLE None
2 NDC:63304-211-01 100 TABLET (TABLET) in 1 BOTTLE None
3 NDC:63304-211-10 1000 TABLET (TABLET) in 1 BOTTLE None
4 NDC:63304-211-69 1 BLISTER PACK (BLISTER) in 1 BOX contains a BLISTER PACK (63304-211-11)
4 NDC:63304-211-11 10 TABLET (TABLET) in 1 BLISTER PACK This package is contained within the BOX (63304-211-69)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040844 08/18/2009
Labeler — Ranbaxy Pharmaceuticals Inc. (937890044)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 manufacture (63304-210), manufacture (63304-211)

Revised: 01/2013 Ranbaxy Pharmaceuticals Inc.

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