Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Linzess
Product Details
NDC Product Code
0456-1202Application Number
NDA202811Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 20, 2023LinaclotideActive
Code: N0TXR0XR5XClass: ACTIBQuantity: 290 ug in 1 1
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
LEUCINEInactive
Code: GMW67QNF9CClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
Linzess
Product Details
NDC Product Code
0456-1203Application Number
NDA202811Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 20, 2023LinaclotideActive
Code: N0TXR0XR5XClass: ACTIBQuantity: 72 ug in 1 1
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
HISTIDINEInactive
Code: 4QD397987EClass: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990Class: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
Linzess
Product Details
NDC Product Code
0456-1201Application Number
NDA202811Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
September 20, 2023LinaclotideActive
Code: N0TXR0XR5XClass: ACTIBQuantity: 145 ug in 1 1
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
LEUCINEInactive
Code: GMW67QNF9CClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT