Alvimopan

Product NDC: 0591-2312
11-digit product format: 005912312
Labeler code: 0591
Product ID: 0591-2312_e622edd6-9562-416d-918e-1a03dc828c41
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: 2027-12-31
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		2026-11-03
unfinished package	package	0591-2312	0591-2312-00	UNFINISHED	Active or certified unfinished drug listing		2026-11-03

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 44.

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
2026-10-15 13:18:30	2026-09	A208295-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	RS	2019-12-19	`c2088c7a36db…`
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
2026-10-15 13:18:30	2026-09	A208295-001	AB	1	`c2088c7a36db…`
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…`

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: Alvimopan
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALVIMOPAN	12 mg/1

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

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	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