Lorazepam
Lorazepam Tablets, USP CIV
Approved
Approval ID
0c1caa9c-9ef1-459c-86c3-adb939130a9f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2023
Manufacturers
FDA
SUN PHARMACEUTICAL INDUSTRIES INC
DUNS: 146974886
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-773
Application NumberANDA076045
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-774
Application NumberANDA076045
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 2 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-772
Application NumberANDA076045
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 5, 2023
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT