Glycopyrrolate
Glycopyrrolate Injection, USP(For Intramuscular or Intravenous Use)
Approved
Approval ID
02541cfd-b209-49b9-a73f-13ef18dce06d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc.
DUNS: 080548348
Products 2
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
NDC Product Code71288-415
Application NumberANDA212802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 6, 2021
FDA Product Classification
INGREDIENTS (5)
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
glycopyrrolateActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Glycopyrrolate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-414
Application NumberANDA212802
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glycopyrrolate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 6, 2021
FDA Product Classification
INGREDIENTS (5)
glycopyrrolateActive
Quantity: 0.2 mg in 1 mL
Code: V92SO9WP2I
Classification: ACTIB
benzyl alcoholInactive
Code: LKG8494WBH
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT