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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-314
Application NumberANDA090444
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-316
Application NumberANDA090444
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-317
Application NumberANDA090444
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-315
Application NumberANDA090444
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2023
FDA Product Classification
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