NORTRIPTYLINE HYDROCHLORIDE
Nortriptyline Hydrochloride Capsules USPRevised: September 2008Rx only 173679
Approved
Approval ID
651972ea-b8b9-47fb-b84a-d96ef8217c83
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 9, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 Code16590-171
Application NumberANDA073554
Product Classification
M
Marketing Category
C73584
G
Generic Name
NORTRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 9, 2010
FDA Product Classification
INGREDIENTS (15)
NORTRIPTYLINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT