Lorazepam
Lorazepam Tablets USP, CIV Rx Only
Approved
Approval ID
4fae1607-69d7-47ce-9b78-7474af50036d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2022
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-015
Application NumberANDA078826
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2022
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
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-017
Application NumberANDA078826
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2022
FDA Product Classification
INGREDIENTS (5)
LORAZEPAMActive
Quantity: 2 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 Code65162-018
Application NumberANDA078826
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2022
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