Doxepin Hydrochloride
DOXEPIN HYDROCHLORIDE CAPSULES, USP
Approved
Approval ID
24dd378e-0ef9-4ef8-8032-f81c1d87b3b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-441
Application NumberANDA070789
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2007
FDA Product Classification
INGREDIENTS (18)
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Doxepin HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
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 BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-943
Application NumberANDA070791
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2007
FDA Product Classification
INGREDIENTS (18)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Doxepin HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT