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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0273
Application NumberANDA091099
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0274
Application NumberANDA091099
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0276
Application NumberANDA091099
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-0275
Application NumberANDA091099
Product Classification
M
Marketing Category
C73584
G
Generic Name
Imipramine Pamoate
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 3, 2017
FDA Product Classification
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