Home NDC 72603-288 Lubiprostone
Product NDC 72603-288
11-digit product format 726030288
Labeler code 72603
Product ID 72603-288_4d72c56c-4948-4cd4-afc4-e1e0d59622a5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lubiprostone
Dosage form CAPSULE
Route ORAL
Labeler Northstar Rx LLC
Application ANDA218640
Marketing category ANDA
Marketing start 2025-07-01
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 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 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 2026-08-01 22:54:32 2026-06 A218640-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2025-01-02 a50c72e98297…2026-08-01 22:54:32 2026-06 A218640-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2025-01-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A218640-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A218640-002 AB 1 a50c72e98297…
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 · 2 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 .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 72603-288-01 Lubiprostone 60 in 1 BOTTLE CAPSULE 60 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72603-288-01 72603028801 60 CAPSULE in 1 BOTTLE (72603-288-01) 60 capsule 2025-07-01 No No Current