Home DailyMed af136514-bbef-44de-8079-0753642e560d National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:28:24 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N021908-001 AMITIZA LUBIPROSTONE 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 N021908-002 AMITIZA LUBIPROSTONE 8MCG CAPSULE / ORAL AB RLD 2008-04-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021908-001 8338639 2027-01-23 Drug product 2012-12-20 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 N021908-002 8338639 2027-01-23 Drug product N021908-002 8779187 2027-01-23 Drug product 2014-08-07 N021908-002 8026393 2027-10-25 Drug product
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 3 · 86 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 2026-09-14 22:38:34 2026-08 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021908-001 AMITIZA 24MCG CAPSULE / ORAL AB RLD, RS 2006-01-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021908-002 AMITIZA 8MCG CAPSULE / ORAL AB RLD 2008-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021908-001 AMITIZA 24MCG CAPSULE / ORAL RLD, RS 2006-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021908-002 AMITIZA 8MCG CAPSULE / ORAL RLD 2008-04-29 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
Observed Orange Book patent history# Patent history page 1 of 16 · 635 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N021908-001 8338639 2027-01-23 Drug product 2012-12-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021908-002 8338639 2027-01-23 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021908-002 8779187 2027-01-23 Drug product 2014-08-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021908-002 8026393 2027-10-25 Drug product 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021908-001 8338639 2027-01-23 Drug product 2012-12-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021908-002 8338639 2027-01-23 Drug product caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021908-002 8779187 2027-01-23 Drug product 2014-08-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021908-002 8026393 2027-10-25 Drug product caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021908-001 8338639 2027-01-23 Drug product 2012-12-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021908-002 8338639 2027-01-23 Drug product 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021908-002 8779187 2027-01-23 Drug product 2014-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021908-002 8026393 2027-10-25 Drug product 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-001 8748481 2025-09-01 U-1520 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-001 8338639 2027-01-23 Drug product 2012-12-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-002 8748481 2025-09-01 U-1519 2014-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-002 8338639 2027-01-23 Drug product 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-002 8779187 2027-01-23 Drug product 2014-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021908-002 8026393 2027-10-25 Drug product 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021908-001 8748481 2025-09-01 U-1520 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-001 8338639 2027-01-23 Drug product 2012-12-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-002 8748481 2025-09-01 U-1519 2014-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-002 8338639 2027-01-23 Drug product 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-002 8779187 2027-01-23 Drug product 2014-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021908-002 8026393 2027-10-25 Drug product 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-001 8748481 2025-09-01 U-1520 2014-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-001 8338639 2027-01-23 Drug product 2012-12-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-001 8779187 2027-01-23 Drug product 2014-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-001 8026393 2027-10-25 Drug product 2011-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-002 8748481 2025-09-01 U-1519 2014-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021908-002 8338639 2027-01-23 Drug product fd3edfee7708…
Observed Orange Book exclusivity history# 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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.