Home NDC 0591-2312 Alvimopan
Product NDC 0591-2312
11-digit product format 005912312
Labeler code 0591
Product ID 0591-2312_ef9ffdef-f019-4329-b6a4-658fa872d3b8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alvimopan
Dosage form CAPSULE
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA208295
Marketing category ANDA
Marketing start 2020-12-01
Substance ALVIMOPAN
Active strength 12 mg/1
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0591-2312 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0591-2312 0591-2312-00 UNFINISHED Active or certified unfinished drug listing 2026-09-14
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 0591-2312-00 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 0591-2312-00 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 0591-2312-00 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 0591-2312-00 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 0591-2312-00 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 0591-2312-00 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 0591-2312-00 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 0591-2312-00 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 0591-2312-00 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 0591-2312-00 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 0591-2312-00 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 0591-2312-00 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 0591-2312-00 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 0591-2312-00 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 0591-2312-00 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 0591-2312-00 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 0591-2312-00 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 0591-2312-00 4184dd79f89f…545327b3e20f…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208295-001 ALVIMOPAN ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208295-001 AB
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.
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 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL 2019-12-19 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2019-12-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208295-001 ALVIMOPAN 12MG CAPSULE / ORAL AB RS 2019-12-19 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Alvimopan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALVIMOPAN 12 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 677C126AET Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 799835 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 0591-2312-15 Alvimopan 30 in 1 CARTON CAPSULE 30 5 0591-2312-45 Alvimopan 1 in 1 BLISTER PACK CAPSULE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0591-2312 ALVIMOPAN CAPSULE [ACTAVIS PHARMA, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240125_2a0645b4-daf8-421f-b987-a4e478843c5d.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 0591-2312-00 00591231200 20000 CAPSULE in 1 BOX (0591-2312-00) 20000 capsule 13-OCT-20 Current 0591-2312-15 00591231215 30 BLISTER PACK in 1 CARTON (0591-2312-15) / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45) 30 blister pack 2020-12-01 0000-00-00 No No Current 0591-2312-45 00591231245 1 in 1 BLISTER PACK Historical