Home NDC 76420-778 Lubiprostone
Product NDC 76420-778
11-digit product format 764200778
Labeler code 76420
Product ID 76420-778_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 24 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 42 .
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 · 48 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 2026-08-18 06:07:40 2026-07 A214131-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2023-03-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214131-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2023-03-23 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 48 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lubiprostone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUBIPROSTONE 24 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 76420-778-01 Lubiprostone 100 in 1 BOTTLE CAPSULE 100 1 76420-778-30 Lubiprostone 30 in 1 BOTTLE CAPSULE 30 1 76420-778-60 Lubiprostone 60 in 1 BOTTLE CAPSULE 60 1 76420-778-90 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 76420-778 LUBIPROSTONE CAPSULE [ASCLEMED USA, INC.] 1 Current NDC, 4 package rows 20250210_5797e57c-4e87-48d9-b16d-992f64db594f.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 · 3 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 76420-778-01 76420077801 100 CAPSULE in 1 BOTTLE (76420-778-01) 100 capsule 2025-02-07 No No Current 76420-778-30 76420077830 30 CAPSULE in 1 BOTTLE (76420-778-30) 30 capsule 2025-02-07 No No Current 76420-778-60 76420077860 60 CAPSULE in 1 BOTTLE (76420-778-60) 60 capsule 2025-02-07 No No Current 76420-778-90 76420077890 90 CAPSULE in 1 BOTTLE (76420-778-90) 90 capsule 2025-02-07 No No Current