Loxapine
LOXAPINE CAPSULES, USP Rx Only
Approved
Approval ID
a0cc7bb6-075f-47d1-8935-eb77a29d8c45
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2019
Manufacturers
FDA
Elite Laboratories, Inc.
DUNS: 785398728
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Loxapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-892
Application NumberANDA076868
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loxapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (16)
Loxapine SuccinateActive
Quantity: 25 mg in 1 1
Code: X59SG0MRYU
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Fd&C Blue No. 1 Aluminum LakeInactive
Code: J9EQA3S2JM
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Loxapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-891
Application NumberANDA076868
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loxapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (17)
Loxapine SuccinateActive
Quantity: 10 mg in 1 1
Code: X59SG0MRYU
Classification: ACTIM
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Fd&C Blue No. 1 Aluminum LakeInactive
Code: J9EQA3S2JM
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Loxapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-893
Application NumberANDA076868
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loxapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (16)
Loxapine SuccinateActive
Quantity: 50 mg in 1 1
Code: X59SG0MRYU
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Fd&C Blue No. 1 Aluminum LakeInactive
Code: J9EQA3S2JM
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
Loxapine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-890
Application NumberANDA076868
Product Classification
M
Marketing Category
C73584
G
Generic Name
Loxapine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2022
FDA Product Classification
INGREDIENTS (16)
Loxapine SuccinateActive
Quantity: 5 mg in 1 1
Code: X59SG0MRYU
Classification: ACTIM
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Hypromellose, UnspecifiedInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Fd&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Fd&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Fd&C Blue No. 2--Aluminum LakeInactive
Code: 4AQJ3LG584
Classification: IACT
Fd&C Blue No. 1 Aluminum LakeInactive
Code: J9EQA3S2JM
Classification: IACT
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Fd&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT