Ativan
ATIVAN Injection (lorazepam injection, USP)
Approved
Approval ID
5fc0e987-61c9-40c4-b0d5-fcea07c8733e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 946499746
Products 4
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 Code0641-6002
Application NumberNDA018140
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (4)
LORAZEPAMActive
Quantity: 4.0 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Quantity: 0.18 mL in 1 mL
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6001
Application NumberNDA018140
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (4)
LORAZEPAMActive
Quantity: 2.0 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Quantity: 0.18 mL in 1 mL
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6003
Application NumberNDA018140
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (4)
LORAZEPAMActive
Quantity: 4.0 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Quantity: 0.18 mL in 1 mL
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
Lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0641-6000
Application NumberNDA018140
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lorazepam
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 7, 2023
FDA Product Classification
INGREDIENTS (4)
LORAZEPAMActive
Quantity: 2.0 mg in 1 mL
Code: O26FZP769L
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Quantity: 0.18 mL in 1 mL
Code: B697894SGQ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT