Home NDC 0054-0668 Alvimopan
Product NDC 0054-0668
11-digit product format 000540668
Labeler code 0054
Product ID 0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alvimopan
Dosage form CAPSULE
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA217753
Marketing category ANDA
Marketing start 2024-02-06
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 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 A217753-001 ALVIMOPAN ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217753-001 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 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217753-001 ALVIMOPAN 12MG CAPSULE / ORAL AB 2023-08-31 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 0054-0668-82 Alvimopan 6 in 1 CARTON CAPSULE 6 2 0054-0668-82 Alvimopan 5 in 1 BLISTER PACK CAPSULE 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0668 ALVIMOPAN CAPSULE [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, 2 package rows 20240207_59ef406b-79db-4efd-b993-08b937ac682b.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0054-0668-82 00054066882 6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK 6 blister pack 2024-02-06 No No Current