Home NDC 0480-3479 Lubiprostone
Product NDC 0480-3479
11-digit product format 004803479
Labeler code 0480
Product ID 0480-3479_22f53da2-2fb9-411d-baad-fef011383f6f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lubiprostone
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA209920
Marketing category ANDA
Marketing start 2023-01-03
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 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 · 64 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 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…2024-02-18 07:12 UTC 2024-02 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 1c564ffb4f44…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 58 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 · 4 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 0480-3479-06 Lubiprostone 60 in 1 BOTTLE CAPSULE, GELATIN COATED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0480-3479 LUBIPROSTONE CAPSULE, GELATIN COATED [TEVA PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 1 package rows 20230105_e17b521e-2c25-4bef-82f9-7916fa79bca4.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0480-3479-06 00480347906 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0480-3479-06) 2023-01-03 0000-00-00 No No Current