Home NDC 76420-777 Lubiprostone
Product NDC 76420-777
11-digit product format 764200777
Labeler code 76420
Product ID 76420-777_2d872107-0284-f85f-e063-6394a90a6258
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lubiprostone
Dosage form CAPSULE
Route ORAL
Labeler Asclemed USA, Inc.
Application ANDA214131
Marketing category ANDA
Marketing start 2023-03-23
Substance LUBIPROSTONE
Active strength 8 ug/1
Pharmacologic classes Chloride Channel Activator [EPC], Chloride Channel Activators [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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214131-001 LUBIPROSTONE LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 A214131-002 LUBIPROSTONE LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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.
Product history page 1 of 2 · 46 observed 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 2026-02-19 14:30 UTC 2026-02 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 3 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Lubiprostone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUBIPROSTONE 8 ug/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7662KG2R6K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 616578 Internal RxNorm lookup 794639 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 76420-777-01 Lubiprostone 100 in 1 BOTTLE CAPSULE 100 1 76420-777-30 Lubiprostone 30 in 1 BOTTLE CAPSULE 30 1 76420-777-60 Lubiprostone 60 in 1 BOTTLE CAPSULE 60 1 76420-777-90 Lubiprostone 90 in 1 BOTTLE CAPSULE 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-777 LUBIPROSTONE CAPSULE [ASCLEMED USA, INC.] 1 Current NDC, 4 package rows 20250210_5797e57c-4e87-48d9-b16d-992f64db594f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 76420-777-01 76420077701 100 CAPSULE in 1 BOTTLE (76420-777-01) 100 capsule 2025-02-07 No No Current 76420-777-30 76420077730 30 CAPSULE in 1 BOTTLE (76420-777-30) 30 capsule 2025-02-07 No No Current 76420-777-60 76420077760 60 CAPSULE in 1 BOTTLE (76420-777-60) 60 capsule 2025-02-07 No No Current 76420-777-90 76420077790 90 CAPSULE in 1 BOTTLE (76420-777-90) 90 capsule 2025-02-07 No No Current