Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
DIRECT RX
079254320
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
DIRECT RX
DIRECT RX
DIRECT RX
079254320
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
72189-177Application Number
ANDA073556Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
February 9, 2021SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
NortriptylineActive
Code: 00FN6IH15DClass: ACTIMQuantity: 50 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT