Alvimopan

Product NDC: 0591-2312
Requested package NDC: 0591-2312-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208295-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208295-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208295-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208295-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208295-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208295-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208295-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208295-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208295-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208295-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208295-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208295-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208295-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208295-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208295-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208295-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208295-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208295-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208295-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208295-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208295-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208295-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208295-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208295-001	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208295-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208295-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208295-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208295-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208295-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208295-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208295-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208295-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208295-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208295-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208295-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208295-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208295-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208295-001	AB	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2a0645b4-daf8-421f-b987-a4e478843c5d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
38d8554a-716f-45e2-84ba-2c075564c43f	Product name	1	20240223
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
fd930e64-3dd0-2bde-97f6-1dbcf5636627	Product name	1	20140508

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2312-45	EA - Each	0591-2312	f399f53b-b133-4714-8682-4aee4968a09c	1	2021-01-08

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alvimopan	ALVIMOPAN	Actavis Pharma, Inc.	2a0645b4-daf8-421f-b987-a4e478843c5d	2021-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208295 application number: ANDA208295 ndc (product): 0591-2312

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
677C126AET	ALVIMOPAN	170098-38-1	ALVIMOPAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
799835	alvimopan 12 MG Oral Capsule	PSN	2a0645b4-daf8-421f-b987-a4e478843c5d	5
799835	alvimopan 12 MG Oral Capsule	SCD	2a0645b4-daf8-421f-b987-a4e478843c5d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
0591-2312-00	00591231200	20000 CAPSULE in 1 BOX (0591-2312-00)	20000 capsule	13-OCT-20	Current