Home NDC 60687-827 Lubiprostone
Product NDC 60687-827
11-digit product format 606870827
Labeler code 60687
Product ID 60687-827_4dc7a17c-dac7-1755-e063-6294a90aa2e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lubiprostone
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler American Health Packaging
Application ANDA209920
Marketing category ANDA
Marketing start 2025-11-26
Substance LUBIPROSTONE
Active strength 24 ug/1
Pharmacologic classes Chloride Channel Activator [EPC], Chloride Channel Activators [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 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 A209920-001 LUBIPROSTONE LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 A209920-002 LUBIPROSTONE LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18
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 · 66 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 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Lubiprostone
Listing expiration 2027-12-31 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 60687-827-32 Lubiprostone 20 in 1 CARTON CAPSULE, GELATIN COATED 20 4 60687-827-33 Lubiprostone 1 in 1 BLISTER PACK CAPSULE, GELATIN COATED 1 4
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 · 4 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 60687-827-32 60687082732 20 BLISTER PACK in 1 CARTON (60687-827-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-827-33) 20 blister pack 2025-11-26 No No Current 60687-827-33 60687082733 1 in 1 BLISTER PACK Historical