Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079502574
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nortriptyline Hydrochloride
Product Details
NDC Product Code
63187-322Application Number
ANDA073553Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2019NortriptylineActive
Code: 00FN6IH15DClass: ACTIMQuantity: 10 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT