Linzess
These highlights do not include all the information needed to use LINZESS safely and effectively. See full prescribing information for LINZESS . LINZESS ( linaclotide ) capsules, for oral use Initial U.S. Approval: 2012
Approved
Approval ID
09beda19-56d6-4a56-afdc-9a77b70b2ef3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 12, 2023
Manufacturers
FDA
Allergan, Inc.
DUNS: 144796497
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
linaclotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0456-1202
Application NumberNDA202811
Product Classification
M
Marketing Category
C73594
G
Generic Name
linaclotide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (7)
LINACLOTIDEActive
Quantity: 290 ug in 1 1
Code: N0TXR0XR5X
Classification: ACTIB
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
LEUCINEInactive
Code: GMW67QNF9C
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
linaclotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0456-1203
Application NumberNDA202811
Product Classification
M
Marketing Category
C73594
G
Generic Name
linaclotide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (8)
LINACLOTIDEActive
Quantity: 72 ug in 1 1
Code: N0TXR0XR5X
Classification: ACTIB
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
HISTIDINEInactive
Code: 4QD397987E
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
linaclotide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0456-1201
Application NumberNDA202811
Product Classification
M
Marketing Category
C73594
G
Generic Name
linaclotide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 20, 2023
FDA Product Classification
INGREDIENTS (7)
LINACLOTIDEActive
Quantity: 145 ug in 1 1
Code: N0TXR0XR5X
Classification: ACTIB
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
LEUCINEInactive
Code: GMW67QNF9C
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT