ALVIMOPAN

Product NDC: 0254-3012
11-digit product format: 002543012
Labeler code: 0254
Product ID: 0254-3012_d43941f1-7b52-4e7a-a560-9a8e28a7ac65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALVIMOPAN
Dosage form: CAPSULE
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA216843
Marketing category: ANDA
Marketing start: 2023-05-03
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

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
A216843-001	ALVIMOPAN	ALVIMOPAN	12MG	CAPSULE / ORAL	AB		2023-01-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A216843-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216843-001	ALVIMOPAN	12MG	CAPSULE / ORAL	AB	2023-01-24	`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	A216843-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216843-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A216843-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216843-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216843-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216843-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216843-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216843-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216843-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216843-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216843-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216843-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216843-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216843-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216843-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216843-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216843-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216843-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216843-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216843-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216843-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216843-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A216843-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A216843-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216843-001	AB	1	`a50c72e98297…`

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

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
1cd584de-b704-4d26-8451-e3247ffb8d08	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
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
0254-3012-55	ALVIMOPAN	6 in 1 CARTON	CAPSULE	6		12
0254-3012-55	ALVIMOPAN	5 in 1 BLISTER PACK	CAPSULE	5		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0254-3012-55	EA - Each	0254-3012	b8501cdf-ce98-4333-ac6f-abcc85200adc	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0254-3012	ALVIMOPAN CAPSULE [ENDO USA, INC.]	9	Current NDC, 2 package rows	20240725_1cd584de-b704-4d26-8451-e3247ffb8d08.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	Par Health USA, LLC	1cd584de-b704-4d26-8451-e3247ffb8d08	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216843 application number: ANDA216843 ndc (product): 0254-3012

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	1cd584de-b704-4d26-8451-e3247ffb8d08	12
799835	alvimopan 12 MG Oral Capsule	SCD	1cd584de-b704-4d26-8451-e3247ffb8d08	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0254-3012-55	00254301255	6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK	6 blister pack	2023-05-03	No	No	Current