FDA.reportPublic FDA data

Linzess

Product NDC
0456-1201
11-digit product format
004561201
Labeler code
0456
Product ID
0456-1201_7d31ab60-8fd1-4502-8ff5-33586d9772d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
linaclotide
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA202811
Marketing category
NDA
Marketing start
2012-09-08
Substance
LINACLOTIDE
Active strength
145 ug/1
Pharmacologic classes
Guanylate Cyclase Activators [MoA], Guanylate Cyclase-C Agonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Linzess
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LINACLOTIDE145 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN0TXR0XR5X
Rxcui1307409, 1307415, 1307419, 1307421, 1869697, 1869699

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
e398eb8a-37a1-aa89-6dd2-150ddfb47e9bProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-1201-04Linzess4 in 1 BOTTLECAPSULE, GELATIN COATED438
0456-1201-04Linzess1 in 1 CARTONCAPSULE, GELATIN COATED138
0456-1201-07Linzess1 in 1 CARTONCAPSULE, GELATIN COATED138
0456-1201-07Linzess7 in 1 BOTTLECAPSULE, GELATIN COATED738
0456-1201-30Linzess1 in 1 CARTONCAPSULE, GELATIN COATED138
0456-1201-30Linzess30 in 1 BOTTLECAPSULE, GELATIN COATED3038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-1201-30EA - Each0456-1201a95b4368-55fb-4d23-bc04-e052b2d1d8c312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
linaclotideACTIVE INGREDIENTN0TXR0XR5XLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
linaclotideACTIVE MOIETYN0TXR0XR5XLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5MLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61ULINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
gelatinINACTIVE INGREDIENT2G86QN327LLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
hypromellosesINACTIVE INGREDIENT3NXW29V3WOLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
LeucineINACTIVE INGREDIENTGMW67QNF9CLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPLINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-1201LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [ALLERGAN, INC.]34Current NDC, Legacy NDC, 6 package rows20240711_09beda19-56d6-4a56-afdc-9a77b70b2ef3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307409linaclotide 145 MCG Oral CapsulePSN09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307419linaclotide 290 MCG Oral CapsulePSN09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869697linaclotide 72 MCG Oral CapsulePSN09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307415Linzess 145 MCG Oral CapsulePSN09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307421Linzess 290 MCG Oral CapsulePSN09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869699Linzess 72 MCG Oral CapsulePSN09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869699linaclotide 0.072 MG Oral Capsule [Linzess]SBD09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307415linaclotide 0.145 MG Oral Capsule [Linzess]SBD09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307421linaclotide 0.29 MG Oral Capsule [Linzess]SBD09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869697linaclotide 0.072 MG Oral CapsuleSCD09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307409linaclotide 0.145 MG Oral CapsuleSCD09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307419linaclotide 0.29 MG Oral CapsuleSCD09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307409linaclotide 145 MCG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307419linaclotide 290 MCG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869697linaclotide 72 MCG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869699Linzess 0.072 MG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307415Linzess 0.145 MG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307421Linzess 0.29 MG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307415Linzess 145 MCG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1307421Linzess 290 MCG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339
1869699Linzess 72 MCG Oral CapsuleSY09beda19-56d6-4a56-afdc-9a77b70b2ef339

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-1201-04004561201041 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2012-09-080000-00-00YesNoCurrent
0456-1201-07004561201071 BOTTLE in 1 CARTON (0456-1201-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2019-05-17YesNoHistorical
0456-1201-30004561201301 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE1 bottle2012-09-080000-00-00NoNoCurrent