Home DailyMed 89207e83-860d-4d07-a0b2-2e01ea694abc 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 02:12:00 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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.