ANAFRANIL
Anafranil (clomipramine hydrochloride) Capsules USP (25 mg, 50 mg, and 75 mg) Rx only
Approved
Approval ID
4074b555-7635-41a9-809d-fae3b3610059
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 29, 2023
Manufacturers
FDA
SpecGx LLC
DUNS: 080679498
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
clomipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-9908
Application NumberNDA019906
Product Classification
M
Marketing Category
C73594
G
Generic Name
clomipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (9)
CLOMIPRAMINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 2LXW0L6GWJ
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
clomipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-9906
Application NumberNDA019906
Product Classification
M
Marketing Category
C73594
G
Generic Name
clomipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (10)
CLOMIPRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 2LXW0L6GWJ
Classification: ACTIB
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
clomipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0406-9907
Application NumberNDA019906
Product Classification
M
Marketing Category
C73594
G
Generic Name
clomipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 29, 2023
FDA Product Classification
INGREDIENTS (10)
CLOMIPRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 2LXW0L6GWJ
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT