Home NDC 61874-075 Viberzi
Product NDC 61874-075
11-digit product format 618740075
Labeler code 61874
Product ID 61874-075_772a8af8-21e9-46bb-af21-34365ae0c477
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Eluxadoline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Allergan, Inc.
Application NDA206940
Marketing category NDA
Marketing start 2015-10-01
Substance ELUXADOLINE
Active strength 75 mg/1
Pharmacologic classes Opioid mu-Receptor Agonists [MoA], mu-Opioid Receptor Agonist [EPC]
DEA schedule CIV
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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N206940-001 VIBERZI ELUXADOLINE 75MG TABLET / ORAL RLD 2015-05-27 N206940-002 VIBERZI ELUXADOLINE 100MG TABLET / ORAL RLD, RS 2015-05-27
Orange Book patents# Current patent rows page 1 of 1 · 28 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206940-001 8691860 2028-07-07 U-1709 Drug substance 2015-06-26 N206940-001 9115091 2028-07-07 U-1738 Drug substance, Drug product 2015-09-23 N206940-001 9364489 2028-07-07 U-1709 2016-07-14 N206940-001 9789125 2028-07-07 U-1709 Drug product 2017-11-01 N206940-001 9789125 2028-07-07 U-2152 Drug product 2017-11-01 N206940-001 7741356 2029-05-27 Drug substance, Drug product 2015-06-26 N206940-001 10188632 2033-03-14 Drug product 2019-02-28 N206940-001 11007179 2033-03-14 Drug product 2021-06-03 N206940-001 11090291 2033-03-14 Drug product 2021-09-07 N206940-001 11160792 2033-03-14 Drug product 2021-11-24 N206940-001 11229627 2033-03-14 Drug product 2022-02-15 N206940-001 11311516 2033-03-14 Drug product 2022-05-19 N206940-001 12097187 2033-03-14 U-3475 2024-10-21 N206940-001 9675587 2033-03-14 Drug product 2017-08-07 N206940-002 8691860 2028-07-07 U-1709 Drug substance 2015-06-26 N206940-002 9115091 2028-07-07 U-1738 Drug substance, Drug product 2015-09-23 N206940-002 9364489 2028-07-07 U-1709 2016-07-14 N206940-002 9789125 2028-07-07 U-1709 Drug product 2017-11-01 N206940-002 9789125 2028-07-07 U-2152 Drug product 2017-11-01 N206940-002 7741356 2029-05-27 Drug substance, Drug product 2015-06-26 N206940-002 10188632 2033-03-14 Drug product 2019-02-28 N206940-002 11007179 2033-03-14 Drug product 2021-06-03 N206940-002 11090291 2033-03-14 Drug product 2021-09-07 N206940-002 11160792 2033-03-14 Drug product 2021-11-24 N206940-002 11229627 2033-03-14 Drug product 2022-02-15 N206940-002 11311516 2033-03-14 Drug product 2022-05-19 N206940-002 11484527 2033-03-14 U-3475 2022-11-22 N206940-002 9675587 2033-03-14 Drug product 2017-08-07
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206940-001 VIBERZI 75MG TABLET / ORAL AB RLD 2015-05-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206940-002 VIBERZI 100MG TABLET / ORAL AB RLD, RS 2015-05-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206940-001 VIBERZI 75MG TABLET / ORAL RLD 2015-05-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N206940-002 VIBERZI 100MG TABLET / ORAL RLD, RS 2015-05-27 782e0a99824c…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2025-08-23 18:47 UTC 2025-08 N206940-001 AB 1 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206940-002 AB 1 6a471c1ec25d…
Observed Orange Book patent history# Patent history page 1 of 39 · 1,553 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N206940-001 8691860 2028-07-07 U-1709 Drug substance 2015-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 9115091 2028-07-07 U-1738 Drug substance, Drug product 2015-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 9364489 2028-07-07 U-1709 2016-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 9789125 2028-07-07 U-2152 Drug product 2017-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 9789125 2028-07-07 U-1709 Drug product 2017-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 7741356 2029-05-27 Drug substance, Drug product 2015-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 10188632 2033-03-14 Drug product 2019-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 11007179 2033-03-14 Drug product 2021-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 11090291 2033-03-14 Drug product 2021-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 11160792 2033-03-14 Drug product 2021-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 11229627 2033-03-14 Drug product 2022-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 11311516 2033-03-14 Drug product 2022-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 12097187 2033-03-14 U-3475 2024-10-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-001 9675587 2033-03-14 Drug product 2017-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 8691860 2028-07-07 U-1709 Drug substance 2015-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 9115091 2028-07-07 U-1738 Drug substance, Drug product 2015-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 9364489 2028-07-07 U-1709 2016-07-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 9789125 2028-07-07 U-1709 Drug product 2017-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 9789125 2028-07-07 U-2152 Drug product 2017-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 7741356 2029-05-27 Drug substance, Drug product 2015-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 10188632 2033-03-14 Drug product 2019-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 11007179 2033-03-14 Drug product 2021-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 11090291 2033-03-14 Drug product 2021-09-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 11160792 2033-03-14 Drug product 2021-11-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 11229627 2033-03-14 Drug product 2022-02-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 11311516 2033-03-14 Drug product 2022-05-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 11484527 2033-03-14 U-3475 2022-11-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206940-002 9675587 2033-03-14 Drug product 2017-08-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 10213415 2025-03-14 U-2152 Drug substance 2019-03-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 7786158 2025-03-14 Drug substance 2015-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 8344011 2025-03-14 U-1709 2015-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 8609709 2025-03-14 Drug substance 2015-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 8772325 2025-03-14 U-1709 2017-02-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 9205076 2025-03-14 U-1709 2015-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 9700542 2025-03-14 Drug product 2017-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 8691860 2028-07-07 U-1709 Drug substance 2015-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 9115091 2028-07-07 U-1738 Drug substance, Drug product 2015-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 9364489 2028-07-07 U-1709 2016-07-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 9789125 2028-07-07 U-2152 Drug product 2017-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206940-001 9789125 2028-07-07 U-1709 Drug product 2017-11-01 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Viberzi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ELUXADOLINE 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 45TPJ4MBQ1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1653786 Internal RxNorm lookup 1653792 Internal RxNorm lookup 1719764 Internal RxNorm lookup 1719766 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61874-075-08 Viberzi 8 in 1 BLISTER PACK TABLET, FILM COATED 8 27 61874-075-08 Viberzi 1 in 1 CARTON TABLET, FILM COATED 1 27 61874-075-16 Viberzi 1 in 1 CARTON TABLET, FILM COATED 1 27 61874-075-16 Viberzi 16 in 1 BLISTER PACK TABLET, FILM COATED 16 27 61874-075-60 Viberzi 1 in 1 CARTON TABLET, FILM COATED 1 27 61874-075-60 Viberzi 60 in 1 BOTTLE TABLET, FILM COATED 60 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Eluxadoline ACTIVE INGREDIENT 45TPJ4MBQ1 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Eluxadoline ACTIVE MOIETY 45TPJ4MBQ1 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Cellulose, Microcrystalline INACTIVE INGREDIENT OP1R32D61U VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Crospovidone INACTIVE INGREDIENT 68401960MK VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Ferric Oxide Red INACTIVE INGREDIENT 1K09F3G675 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Ferric Oxide Yellow INACTIVE INGREDIENT EX438O2MRT VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Mannitol INACTIVE INGREDIENT 3OWL53L36A VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Polyvinyl Alcohol INACTIVE INGREDIENT 532B59J990 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Talc INACTIVE INGREDIENT 7SEV7J4R1U VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ACTAVIS PHARMA, INC] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61874-075 VIBERZI (ELUXADOLINE) TABLET, FILM COATED [ALLERGAN, INC.] 23 Current NDC, Legacy NDC, 6 package rows 20250116_7821bd40-4c84-4984-951b-6436ae20421a.zip
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.
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 61874-075-08 61874007508 1 BLISTER PACK in 1 CARTON (61874-075-08) / 8 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2015-10-01 Yes No Historical 61874-075-16 61874007516 1 BLISTER PACK in 1 CARTON (61874-075-16) / 16 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-01-01 Yes No Current 61874-075-60 61874007560 1 BOTTLE in 1 CARTON (61874-075-60) / 60 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2015-10-01 0000-00-00 No No Current