Doxepin Hydrochloride
Doxepin Hydrochloride Capsules
Approved
Approval ID
d78c7bb6-226f-4e6b-8daa-608379f0d1ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2021
Manufacturers
FDA
Edenbridge Pharmaceuticals LLC.
DUNS: 948715060
Products 1
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 Code42799-935
Application NumberANDA213796
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2022
FDA Product Classification
INGREDIENTS (11)
DOXEPIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT