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
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
NORTRIPTYLINE HCI
Product Details
NDC Product Code
61919-285Application Number
ANDA075520Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 11, 2019NortriptylineActive
Code: 00FN6IH15DClass: ACTIMQuantity: 25 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
Nortriptyline HCL
Product Details
NDC Product Code
61919-742Application Number
ANDA073556Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 11, 2019NortriptylineActive
Code: 00FN6IH15DClass: ACTIMQuantity: 50 mg in 1 1
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8Class: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42INClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGFClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT