GLYCOPYRROLATE
Glycopyrrolate Tablets, USP Rx Only
Approved
Approval ID
db178372-51d2-4194-bbe2-da9acb1cfd53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 9, 2020
Manufacturers
FDA
Alembic Labs LLC
DUNS: 167618912
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 Code15955-318
Application NumberANDA203657
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 9, 2020
Generic NameGLYCOPYRROLATE
INGREDIENTS (6)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 2 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLYCOPYRROLATE
PRODUCT DETAILS
NDC Product Code15955-305
Application NumberANDA203657
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 9, 2020
Generic NameGLYCOPYRROLATE
INGREDIENTS (6)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLYCOPYRROLATEActive
Quantity: 1 mg in 1 1
Code: V92SO9WP2I
Classification: ACTIB
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT