Nortriptyline Hydrochloride
NORTRIPTYLINE HYDROCHLORIDE CAPSULES USP Rx only
Approved
Approval ID
e047f990-c374-4f8f-8583-c615f92545e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
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 Code71205-254
Application NumberANDA074132
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nortriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2022
FDA Product Classification
INGREDIENTS (16)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
NORTRIPTYLINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT