Doxepin Hydrochloride
Doxepin Hydrochloride Capsules
Approved
Approval ID
71cff7cd-0410-4194-9cdd-af404a869edd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2022
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 6
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 Code49884-218
Application NumberANDA071422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (8)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-219
Application NumberANDA071422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (8)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-221
Application NumberANDA071422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (8)
DOXEPIN HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-220
Application NumberANDA071422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (8)
DOXEPIN HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-222
Application NumberANDA071422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (8)
DOXEPIN HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Doxepin Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-217
Application NumberANDA071422
Product Classification
M
Marketing Category
C73584
G
Generic Name
Doxepin Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2022
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOXEPIN HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 3U9A0FE9N5
Classification: ACTIM
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT