Nortriptyline Hydrochloride
Nortriptyline Hydrochloride Capsules, USP
Approved
Approval ID
aee2c1a1-d848-4c3b-8c6d-8a4f6ce94c28
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 4, 2020
Manufacturers
FDA
Taro Pharmaceuticals U.S.A., Inc.
DUNS: 145186370
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nortriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4001
Application NumberANDA075520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nortriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2020
FDA Product Classification
INGREDIENTS (15)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Nortriptyline HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Green NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
FD&C Red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
Nortriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4003
Application NumberANDA075520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nortriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2020
FDA Product Classification
INGREDIENTS (14)
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Nortriptyline HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FD&C Green NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Nortriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4004
Application NumberANDA075520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nortriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2020
FDA Product Classification
INGREDIENTS (14)
Nortriptyline HydrochlorideActive
Quantity: 75 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Green NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Nortriptyline Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51672-4002
Application NumberANDA075520
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nortriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMay 4, 2020
FDA Product Classification
INGREDIENTS (14)
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Nortriptyline HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
FD&C Red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT