Lorazepam
Lorazepam Tablets, USP CIV Rx only
Approved
Approval ID
4a50329b-b272-4164-bddf-0d6cea3d7a23
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 25, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
Products 1
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 Code68788-7355
Application NumberANDA203572
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2023
FDA Product Classification
INGREDIENTS (5)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
LORAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT