Lorazepam
LORAZEPAM TABLETS, USP
Approved
Approval ID
809537e2-c85b-4587-a3c6-f252334d503f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2013
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
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 Code66336-363
Application NumberANDA071403
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2013
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 0.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT