Molindone Hydrochloride
Molindone Hydrochloride Tablets
Approved
Approval ID
1275e92f-9573-4d0c-8e77-1c9ac47696d2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
EPIC PHARMA, LLC
DUNS: 827915443
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Molindone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-336
Application NumberANDA090453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Molindone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2019
FDA Product Classification
INGREDIENTS (10)
MOLINDONE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 1DWS68PNE6
Classification: ACTIB
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CALCIUM SULFATE, UNSPECIFIED FORMInactive
Code: WAT0DDB505
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Molindone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-337
Application NumberANDA090453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Molindone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2019
FDA Product Classification
INGREDIENTS (10)
MOLINDONE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1DWS68PNE6
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
CALCIUM SULFATE, UNSPECIFIED FORMInactive
Code: WAT0DDB505
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Molindone Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-338
Application NumberANDA090453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Molindone Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2019
FDA Product Classification
INGREDIENTS (12)
ALGINIC ACIDInactive
Code: 8C3Z4148WZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MOLINDONE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 1DWS68PNE6
Classification: ACTIB
CALCIUM SULFATE, UNSPECIFIED FORMInactive
Code: WAT0DDB505
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT