Imipramine Pamoate
Imipramine Pamoate Capsules USPFor oral administration Rx only
Approved
Approval ID
d1dde497-1889-4424-af18-da7ca6459cf3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
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 Code68180-314
Application NumberANDA090444
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 1, 2023
Generic NameImipramine Pamoate
INGREDIENTS (10)
IMIPRAMINE PAMOATEActive
Quantity: 75 mg in 1 1
Code: MC34P30298
Classification: ACTIR
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code68180-316
Application NumberANDA090444
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 1, 2023
Generic NameImipramine Pamoate
INGREDIENTS (11)
IMIPRAMINE PAMOATEActive
Quantity: 125 mg in 1 1
Code: MC34P30298
Classification: ACTIR
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code68180-317
Application NumberANDA090444
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 1, 2023
Generic NameImipramine Pamoate
INGREDIENTS (10)
IMIPRAMINE PAMOATEActive
Quantity: 150 mg in 1 1
Code: MC34P30298
Classification: ACTIR
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Imipramine Pamoate
PRODUCT DETAILS
NDC Product Code68180-315
Application NumberANDA090444
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 1, 2023
Generic NameImipramine Pamoate
INGREDIENTS (11)
IMIPRAMINE PAMOATEActive
Quantity: 100 mg in 1 1
Code: MC34P30298
Classification: ACTIR
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT