Lorazepam
LORAZEPAM TABLETS, USP CIV 40-8993 Revised – August 2007 Rx only
Approved
Approval ID
0209bb1e-b8fa-4fa9-a533-4dda028bd369
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 29, 2011
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-980
Application NumberANDA071403
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2008
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
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-981
Application NumberANDA071404
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2008
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-982
Application NumberANDA071141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2008
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LORAZEPAMActive
Quantity: 2 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
POLACRILIN POTASSIUMInactive
Code: 0BZ5A00FQU
Classification: IACT