Label: GLYCOPYRROLATE injection
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NDC Code(s):
70771-1616-1,
70771-1616-6,
70771-1617-7,
70771-1618-1, view more70771-1618-7, 70771-1619-1, 70771-1619-6
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 5, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Glycopyrrolate Injection, USP
0.2 mg/mL
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
1 mL Single-Dose Vial
Rx only
Glycopyrrolate Injection, USP
0.2 mg/mL
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
25 x 1 mL Single-Dose Vials
Rx only
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
2 mL Single-Dose Vial
Rx only
Glycopyrrolate Injection, USP
0.4 mg/2 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
25 x 2 mL Single-Dose Vials
Rx only
Glycopyrrolate Injection, USP
1 mg/5 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
5 mL Multiple-Dose Vial
Rx only
Glycopyrrolate Injection, USP
1 mg/5 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
25 x 5 mL Multiple-Dose Vials
Rx only
Glycopyrrolate Injection, USP
4 mg/20 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR
INTRAVENOUS ADMINISTRATION
20 mL Multiple-Dose Vial
Rx only
Glycopyrrolate Injection, USP
4 mg/20 mL
(0.2 mg/mL)
NOT FOR USE IN NEWBORNS
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRAVENOUS ADMINISTRATION
10 x 20 mL Multiple-Dose Vials
Rx only
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INGREDIENTS AND APPEARANCE
GLYCOPYRROLATE
glycopyrrolate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1616 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1616-6 25 in 1 CARTON 11/18/2021 1 NDC:70771-1616-1 1 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214213 11/18/2021 GLYCOPYRROLATE
glycopyrrolate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1617 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1617-7 2 mL in 1 VIAL; Type 0: Not a Combination Product 11/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214213 11/18/2021 GLYCOPYRROLATE
glycopyrrolate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1618 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1618-7 25 in 1 CARTON 11/18/2021 1 NDC:70771-1618-1 5 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214213 11/18/2021 GLYCOPYRROLATE
glycopyrrolate injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1619 Route of Administration INTRAMUSCULAR, INTRAVENOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCOPYRROLATE (UNII: V92SO9WP2I) (GLYCOPYRRONIUM - UNII:A14FB57V1D) GLYCOPYRROLATE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) 9 mg in 1 mL HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1619-6 10 in 1 CARTON 11/18/2021 1 NDC:70771-1619-1 20 mL in 1 VIAL; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA214213 11/18/2021 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Lifesciences Limited 873671928 MANUFACTURE(70771-1616, 70771-1617, 70771-1618, 70771-1619) , ANALYSIS(70771-1616, 70771-1617, 70771-1618, 70771-1619)