Nortriptyline Hydrochloride
Nortriptyline Hydrochloride Capsules USP Revised: March 2013 Rx only
Approved
Approval ID
8babce09-077e-490f-a6e9-983c0cdde27b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2019
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 Code63187-322
Application NumberANDA073553
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nortriptyline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2019
FDA Product Classification
INGREDIENTS (15)
NORTRIPTYLINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT