Trimipramine Maleate
TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG and 100 MG Rx Only
Approved
Approval ID
59c25dd3-7ab0-4e7f-b839-367db9eeccd2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 29, 2019
Manufacturers
FDA
Elite Laboratories, Inc.
DUNS: 785398728
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trimipramine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-851
Application NumberANDA077361
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimipramine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (13)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
TRIMIPRAMINE MALEATEActive
Quantity: 50 mg in 1 1
Code: 269K6498LD
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Trimipramine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-850
Application NumberANDA077361
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimipramine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (13)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
TRIMIPRAMINE MALEATEActive
Quantity: 25 mg in 1 1
Code: 269K6498LD
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Trimipramine Maleate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64850-852
Application NumberANDA077361
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimipramine Maleate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (11)
TRIMIPRAMINE MALEATEActive
Quantity: 100 mg in 1 1
Code: 269K6498LD
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT