Home NDC 0456-1203 Linzess
Product NDC 0456-1203
11-digit product format 004561203
Labeler code 0456
Product ID 0456-1203_ca3006ec-2b5c-4dda-870a-685e831fa4a0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linaclotide
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Allergan, Inc.
Application NDA202811
Marketing category NDA
Marketing start 2017-01-30
Substance LINACLOTIDE
Active strength 72 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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N202811-001 LINZESS LINACLOTIDE 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 N202811-002 LINZESS LINACLOTIDE 290MCG CAPSULE / ORAL RLD 2012-08-30 N202811-003 LINZESS LINACLOTIDE 72MCG CAPSULE / ORAL AB RLD, RS 2017-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N202811-003 AB
Orange Book patents# Current patent rows page 1 of 1 · 46 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N202811-001 7304036 2026-08-30 U-1278 Drug substance, Drug product 2012-09-18 N202811-001 7304036 2026-08-30 U-1516 Drug substance, Drug product 2012-09-18 N202811-001 7304036 2026-08-30 U-4345 Drug substance, Drug product 2012-09-18 N202811-001 7304036*PED 2027-02-28 Pediatric extension N202811-001 8933030 2031-02-17 U-4345 Drug product 2015-02-06 N202811-001 8933030*PED 2031-08-17 Pediatric extension N202811-001 8748573 2031-10-30 U-1515 2014-06-11 N202811-001 8748573 2031-10-30 U-1516 2014-06-11 N202811-001 8748573 2031-10-30 U-4345 2014-06-11 N202811-001 8802628 2031-10-30 Drug product 2014-08-19 N202811-001 8748573*PED 2032-04-30 Pediatric extension N202811-001 8802628*PED 2032-04-30 Pediatric extension N202811-001 9708371 2033-08-16 U-1515 Drug product 2017-08-10 N202811-001 9708371 2033-08-16 U-1516 Drug product 2017-08-10 N202811-001 9708371 2033-08-16 U-4345 Drug product 2017-08-10 N202811-001 9708371*PED 2034-02-16 Pediatric extension N202811-002 7304036 2026-08-30 U-1278 Drug substance, Drug product N202811-002 7304036 2026-08-30 U-1516 Drug substance, Drug product N202811-002 7304036*PED 2027-02-28 Pediatric extension N202811-002 8933030 2031-02-17 Drug product 2015-02-06 N202811-002 8933030*PED 2031-08-17 Pediatric extension N202811-002 8748573 2031-10-30 U-1515 2014-06-11 N202811-002 8748573 2031-10-30 U-1516 2014-06-11 N202811-002 8802628 2031-10-30 Drug product 2014-08-19 N202811-002 8748573*PED 2032-04-30 Pediatric extension N202811-002 8802628*PED 2032-04-30 Pediatric extension N202811-002 9708371 2033-08-16 U-1515 Drug product 2017-08-10 N202811-002 9708371*PED 2034-02-16 Pediatric extension N202811-003 7304036 2026-08-30 U-1516 Drug substance, Drug product 2017-02-24 N202811-003 7304036 2026-08-30 U-3644 Drug substance, Drug product 2017-02-24 N202811-003 7304036 2026-08-30 U-4566 Drug substance, Drug product 2017-02-24 N202811-003 7304036*PED 2027-02-28 Pediatric extension N202811-003 8933030 2031-02-17 U-1516 Drug product 2017-02-24 N202811-003 8933030 2031-02-17 U-3644 Drug product 2017-02-24 N202811-003 8933030 2031-02-17 U-4566 Drug product 2017-02-24 N202811-003 10675325 2031-08-11 Drug product 2020-06-22 N202811-003 10702576 2031-08-11 U-1516 2020-08-04 N202811-003 10702576 2031-08-11 U-3644 2020-08-04 N202811-003 10702576 2031-08-11 U-4566 2020-08-04 N202811-003 8933030*PED 2031-08-17 Pediatric extension N202811-003 10675325*PED 2032-02-11 Pediatric extension N202811-003 10702576*PED 2032-02-11 Pediatric extension N202811-003 9708371 2033-08-16 U-1516 Drug product 2017-08-10 N202811-003 9708371 2033-08-16 U-3644 Drug product 2017-08-10 N202811-003 9708371 2033-08-16 U-4566 Drug product 2017-08-10 N202811-003 9708371*PED 2034-02-16 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 132 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 LINZESS 72MCG CAPSULE / ORAL AB RLD, RS 2017-01-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 79d66fd596c7…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 41 · 1,628 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N202811-001 7304036 2026-08-30 U-1278 Drug substance, Drug product 2012-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 7304036 2026-08-30 U-4345 Drug substance, Drug product 2012-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 7304036 2026-08-30 U-1516 Drug substance, Drug product 2012-09-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 7304036*PED 2027-02-28 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8933030 2031-02-17 U-4345 Drug product 2015-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8933030*PED 2031-08-17 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8748573 2031-10-30 U-1515 2014-06-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8748573 2031-10-30 U-1516 2014-06-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8748573 2031-10-30 U-4345 2014-06-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8802628 2031-10-30 Drug product 2014-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8748573*PED 2032-04-30 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 8802628*PED 2032-04-30 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 9708371 2033-08-16 U-1515 Drug product 2017-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 9708371 2033-08-16 U-1516 Drug product 2017-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 9708371 2033-08-16 U-4345 Drug product 2017-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-001 9708371*PED 2034-02-16 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 7304036 2026-08-30 U-1278 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 7304036 2026-08-30 U-1516 Drug substance, Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 7304036*PED 2027-02-28 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8933030 2031-02-17 Drug product 2015-02-06 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8933030*PED 2031-08-17 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8748573 2031-10-30 U-1516 2014-06-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8748573 2031-10-30 U-1515 2014-06-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8802628 2031-10-30 Drug product 2014-08-19 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8748573*PED 2032-04-30 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 8802628*PED 2032-04-30 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 9708371 2033-08-16 U-1515 Drug product 2017-08-10 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-002 9708371*PED 2034-02-16 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 7304036 2026-08-30 U-1516 Drug substance, Drug product 2017-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 7304036 2026-08-30 U-3644 Drug substance, Drug product 2017-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 7304036 2026-08-30 U-4566 Drug substance, Drug product 2017-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 7304036*PED 2027-02-28 Pediatric extension c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 8933030 2031-02-17 U-1516 Drug product 2017-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 8933030 2031-02-17 U-3644 Drug product 2017-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 8933030 2031-02-17 U-4566 Drug product 2017-02-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 10675325 2031-08-11 Drug product 2020-06-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 10702576 2031-08-11 U-1516 2020-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 10702576 2031-08-11 U-3644 2020-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 10702576 2031-08-11 U-4566 2020-08-04 c2088c7a36db…2026-10-15 13:18:30 2026-09 N202811-003 8933030*PED 2031-08-17 Pediatric extension c2088c7a36db…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 66 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Linzess
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LINACLOTIDE 72 ug/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0456-1203-04 Linzess 4 in 1 BOTTLE CAPSULE, GELATIN COATED 4 38 0456-1203-04 Linzess 1 in 1 CARTON CAPSULE, GELATIN COATED 1 38 0456-1203-07 Linzess 1 in 1 CARTON CAPSULE, GELATIN COATED 1 38 0456-1203-07 Linzess 7 in 1 BOTTLE CAPSULE, GELATIN COATED 7 38 0456-1203-30 Linzess 1 in 1 CARTON CAPSULE, GELATIN COATED 1 38 0456-1203-30 Linzess 30 in 1 BOTTLE CAPSULE, GELATIN COATED 30 38
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded linaclotide ACTIVE INGREDIENT N0TXR0XR5X LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 linaclotide ACTIVE MOIETY N0TXR0XR5X LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 calcium chloride INACTIVE INGREDIENT M4I0D6VV5M LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 gelatin INACTIVE INGREDIENT 2G86QN327L LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 Leucine INACTIVE INGREDIENT GMW67QNF9C LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [FOREST LABORATORIES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0456-1203 LINZESS (LINACLOTIDE) CAPSULE, GELATIN COATED [ALLERGAN, INC.] 34 Current NDC, Legacy NDC, 6 package rows 20240711_09beda19-56d6-4a56-afdc-9a77b70b2ef3.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0456-1203-04 00456120304 1 BOTTLE in 1 CARTON (0456-1203-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2017-01-30 0000-00-00 Yes No Current 0456-1203-07 00456120307 1 BOTTLE in 1 CARTON (0456-1203-07) / 7 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2019-05-17 Yes No Current 0456-1203-30 00456120330 1 BOTTLE in 1 CARTON (0456-1203-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2017-01-30 0000-00-00 No No Current