Home NDC 31722-403 Lubiprostone
Product NDC 31722-403
11-digit product format 317220403
Labeler code 31722
Product ID 31722-403_5008a4ec-08c5-4d06-bac9-e7239620a07d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lubiprostone
Dosage form CAPSULE
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA218640
Marketing category ANDA
Marketing start 2025-05-27
Substance LUBIPROSTONE
Active strength .008 mg/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 A218640-001 LUBIPROSTONE LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 A218640-002 LUBIPROSTONE LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02
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.
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 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 03ed91905a0d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Lubiprostone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LUBIPROSTONE .008 mg/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 31722-403-60 Lubiprostone 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-403 LUBIPROSTONE CAPSULE [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, 1 package rows 20250528_6d973d7d-a43e-4495-b618-a8ad3142683d.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 · 2 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 31722-403-60 31722040360 60 CAPSULE in 1 BOTTLE (31722-403-60) 60 capsule 2025-05-27 No No Current