Imipramine Pamoate
Imipramine Pamoate Capsules, USP For oral administration Rx only
Approved
Approval ID
6e780825-2a66-41fd-a04c-78fa7c4df05e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2021
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc
DUNS: 080189610
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code0054-0273
Application NumberANDA091099
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 3, 2017
Generic NameImipramine Pamoate
INGREDIENTS (12)
IMIPRAMINE PAMOATEActive
Quantity: 75 mg in 1 1
Code: MC34P30298
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code0054-0274
Application NumberANDA091099
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 3, 2017
Generic NameImipramine Pamoate
INGREDIENTS (13)
IMIPRAMINE PAMOATEActive
Quantity: 100 mg in 1 1
Code: MC34P30298
Classification: ACTIR
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code0054-0276
Application NumberANDA091099
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 3, 2017
Generic NameImipramine Pamoate
INGREDIENTS (12)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
IMIPRAMINE PAMOATEActive
Quantity: 150 mg in 1 1
Code: MC34P30298
Classification: ACTIR
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code0054-0275
Application NumberANDA091099
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateFebruary 3, 2017
Generic NameImipramine Pamoate
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
IMIPRAMINE PAMOATEActive
Quantity: 125 mg in 1 1
Code: MC34P30298
Classification: ACTIR
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROUS OXIDEInactive
Code: G7036X8B5H
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