Home NDC 72189-410 Amitza
Product NDC 72189-410
11-digit product format 721890410
Labeler code 72189
Product ID 72189-410_2c4cfec2-fedf-e007-e063-6294a90a3cf9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lubiprostone
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Direct_Rx
Application ANDA209920
Marketing category ANDA
Marketing start 2023-01-12
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.
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 A209920-001 LUBIPROSTONE 8MCG CAPSULE / ORAL AB 2022-01-18 a50c72e98297…2026-08-01 22:54:32 2026-06 A209920-002 LUBIPROSTONE 24MCG CAPSULE / ORAL AB 2022-01-18 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 A209920-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A209920-002 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 · 4 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Amitza
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 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 72189-410-60 Amitza 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 72189-410 AMITZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [DIRECT_RX] 2 Current NDC, Legacy NDC, 1 package rows 20250123_f2121338-9586-161d-e053-2995a90af908.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72189-410-60 72189041060 60 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60) 2023-01-12 0000-00-00 No No Current