FDA.reportPublic FDA data

Lubiprostone

Product NDC
10370-267
11-digit product format
103700267
Labeler code
10370
Product ID
10370-267_bbbc1583-077b-44ac-a860-32221b21a291
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lubiprostone
Dosage form
CAPSULE
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA201442
Marketing category
ANDA
Marketing start
2020-01-01
Marketing end
0000-00-00
Substance
LUBIPROSTONE
Active strength
24 ug/1
Pharmacologic classes
Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10370-267DDiscontinued by firm2026-08-03
excluded packagepackage10370-26710370-267-02DDiscontinued by firm2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201442-001LUBIPROSTONELUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27
A201442-002LUBIPROSTONELUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27

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 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-278072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-276a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-271c564ffb4f44…
2024-02-18 07:12 UTC2024-02A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-279b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201442-001LUBIPROSTONE8MCGCAPSULE / ORAL2022-06-27a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201442-002LUBIPROSTONE24MCGCAPSULE / ORAL2022-06-27a67488948f0b…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-10-28 04:53 UTC2022-10A201442-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A201442-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A201442-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A201442-002AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201442-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A201442-002AB1cb3db0bc1861…

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10370-267-021037002670260 CAPSULE in 1 BOTTLE (10370-267-02) 60 capsule2020-01-010000-00-00NoNoCurrent