LOREEV XR
These highlights do not include all the information needed to use LOREEV XR safely and effectively. See full prescribing information for LOREEV XR. LOREEV XR (lorazepam) extended-release capsules, for oral use, CIV Initial U.S. Approval: 1977
Approved
Approval ID
227734c1-bf01-9607-73ea-5a1f38a89bd9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 20, 2023
Manufacturers
FDA
Almatica Pharma LLC
DUNS: 962454505
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 Code52427-663
Application NumberNDA214826
Product Classification
M
Marketing Category
C73594
G
Generic Name
lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2021
FDA Product Classification
INGREDIENTS (15)
LORAZEPAMActive
Quantity: 2 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-667
Application NumberNDA214826
Product Classification
M
Marketing Category
C73594
G
Generic Name
lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2021
FDA Product Classification
INGREDIENTS (16)
LORAZEPAMActive
Quantity: 3 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-661
Application NumberNDA214826
Product Classification
M
Marketing Category
C73594
G
Generic Name
lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2021
FDA Product Classification
INGREDIENTS (15)
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
LORAZEPAMActive
Quantity: 1.5 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
lorazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52427-658
Application NumberNDA214826
Product Classification
M
Marketing Category
C73594
G
Generic Name
lorazepam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2021
FDA Product Classification
INGREDIENTS (14)
LORAZEPAMActive
Quantity: 1 mg in 1 1
Code: O26FZP769L
Classification: ACTIB
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT