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
079196022
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
71205-254Application Number
ANDA074132Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
June 1, 2022SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
NortriptylineActive
Code: 00FN6IH15DClass: ACTIMQuantity: 25 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3GClass: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1OClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT