Home NDC 50090-8108 LINZESS
Product NDC 50090-8108
11-digit product format 500908108
Labeler code 50090
Product ID 50090-8108_85c64bef-a2a9-4d9b-95c8-603c5ff4b7e1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name linaclotide
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler A-S Medication Solutions
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 RLD, RS 2017-01-25
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 · 129 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202811-002 LINZESS 290MCG CAPSULE / ORAL RLD 2012-08-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N202811-003 LINZESS 72MCG CAPSULE / ORAL RLD, RS 2017-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N202811-001 LINZESS 145MCG CAPSULE / ORAL RLD, RS 2012-08-30 301d65b070ca…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2021-03-12 10:30 UTC 2021-03 N202811-001 AB 1 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N202811-002 AB 1 5aa47cf7b7d7…
Observed Orange Book patent history# Patent history page 1 of 40 · 1,582 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N202811-001 7304036 2026-08-30 U-1278 Drug substance, Drug product 2012-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 7304036 2026-08-30 U-4345 Drug substance, Drug product 2012-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 7304036 2026-08-30 U-1516 Drug substance, Drug product 2012-09-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 7304036*PED 2027-02-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8933030 2031-02-17 U-4345 Drug product 2015-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8933030*PED 2031-08-17 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8748573 2031-10-30 U-1515 2014-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8748573 2031-10-30 U-1516 2014-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8748573 2031-10-30 U-4345 2014-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8802628 2031-10-30 Drug product 2014-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8748573*PED 2032-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 8802628*PED 2032-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 9708371 2033-08-16 U-1515 Drug product 2017-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 9708371 2033-08-16 U-1516 Drug product 2017-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 9708371 2033-08-16 U-4345 Drug product 2017-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-001 9708371*PED 2034-02-16 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 7304036 2026-08-30 U-1278 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 7304036 2026-08-30 U-1516 Drug substance, Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 7304036*PED 2027-02-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8933030 2031-02-17 Drug product 2015-02-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8933030*PED 2031-08-17 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8748573 2031-10-30 U-1516 2014-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8748573 2031-10-30 U-1515 2014-06-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8802628 2031-10-30 Drug product 2014-08-19 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8748573*PED 2032-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 8802628*PED 2032-04-30 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 9708371 2033-08-16 U-1515 Drug product 2017-08-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-002 9708371*PED 2034-02-16 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 7304036 2026-08-30 U-1516 Drug substance, Drug product 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 7304036 2026-08-30 U-3644 Drug substance, Drug product 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 7304036 2026-08-30 U-4566 Drug substance, Drug product 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 7304036*PED 2027-02-28 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 8933030 2031-02-17 U-1516 Drug product 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 8933030 2031-02-17 U-3644 Drug product 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 8933030 2031-02-17 U-4566 Drug product 2017-02-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 10675325 2031-08-11 Drug product 2020-06-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 10702576 2031-08-11 U-1516 2020-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 10702576 2031-08-11 U-3644 2020-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 10702576 2031-08-11 U-4566 2020-08-04 84e616aacf4f…2026-09-14 22:38:34 2026-08 N202811-003 8933030*PED 2031-08-17 Pediatric extension 84e616aacf4f…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 61 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 145 ug/1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Linzess LINACLOTIDE Allergan, Inc. 09beda19-56d6-4a56-afdc-9a77b70b2ef3 2026-05-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 202811 application number: NDA202811
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 50090-8108-0 50090810800 1 BOTTLE in 1 CARTON (50090-8108-0) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE 1 bottle 2026-10-08 No No Current