Glycopyrrolate
Glycopyrrolate Injection, USP Rx only NOT FOR USE IN NEONATES CONTAINS BENZYL ALCOHOL
6934f467-949f-97cc-e053-2a91aa0a05fb
HUMAN PRESCRIPTION DRUG LABEL
May 23, 2023
Medical Purchasing Solutions, LLC
DUNS: 601458529
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
HOW SUPPLIED SECTION
HOW SUPPLIED
Glycopyrrolate (glycopyrrolate) Injection, 0.2 mg/mL, is available as:
0.2 mg/1 mL Single-dose Vials packaged in 25s (NDC 70069-011-25)
0.4 mg/2 mL (0.2 mg/mL) Single-dose Vials packaged in 25s (NDC 70069- 012-25)
1 mg/5 mL (0.2 mg/mL) Multiple-dose Vials packaged in 25s (NDC 70069- 013-25)
4 mg/20 mL (0.2 mg/mL) Multiple-dose Vials packaged in 25s (NDC 70069- 014-10)
Store at 20** C to 25**** C (68**** F to 77**** F) [See USP Controlled Room Temperature].**
To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For Product Inquiry call 1-800-417-9175.
Manufactured By:
Wintac Limited
Bangalore-562 123
India
Code No.: KR/DRUGS/KTK/28/289/97
Manufactured for:
Somerset Therapeutics, LLC
Mendham, NJ 07945
ST- GLY/P/01
Issued: January 2017