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
NDC Product Code71288-415
Application NumberANDA212802
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 6, 2021
Generic NameGlycopyrrolate
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
NDC Product Code71288-414
Application NumberANDA212802
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateJuly 6, 2021
Generic NameGlycopyrrolate
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