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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15955-318
Application NumberANDA203657
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLYCOPYRROLATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15955-305
Application NumberANDA203657
Product Classification
M
Marketing Category
C73584
G
Generic Name
GLYCOPYRROLATE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 9, 2020
FDA Product Classification
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