Amitiza

Product NDC: 64764-240
Requested package NDC: 64764-240-40
11-digit product format: 647640240
Labeler code: 64764
Product ID: 64764-240_c2ca8178-4da1-42d1-a8b9-ff66dca82649
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lubiprostone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA021908
Marketing category: NDA
Marketing start: 2006-01-31
Marketing end: 2027-03-31
Substance: LUBIPROSTONE
Active strength: 24 ug/1
Pharmacologic classes: Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64764-240	64764-240-40	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 4 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-240	64764-240-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64764-240	64764-240-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64764-240	64764-240-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64764-240	64764-240-40	D	Discontinued by firm	excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
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.

Application-product, TE code table
Application-product	TE code
N021908-001	AB
N021908-002	AB

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL	AB	RLD, RS	2006-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL	AB	RLD	2008-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL	AB	RLD, RS	2006-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL	AB	RLD	2008-04-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021908-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021908-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021908-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021908-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021908-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021908-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021908-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021908-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021908-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021908-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021908-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021908-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021908-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021908-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021908-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021908-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021908-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021908-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021908-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021908-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021908-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021908-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021908-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021908-002	AB	1	`6a51e52b5d6a…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 623 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021908-002	8779187	2027-01-23		Drug product	2014-08-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021908-002	8026393	2027-10-25		Drug product		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-001	8779187	2027-01-23		Drug product	2014-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-001	8026393	2027-10-25		Drug product	2011-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-002	8748481	2025-09-01	U-1519		2014-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-002	8338639	2027-01-23		Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-002	8779187	2027-01-23		Drug product	2014-08-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021908-002	8026393	2027-10-25		Drug product		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`03ed91905a0d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021908-001	M-225	2021-04-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021908-002	M-225	2021-04-26	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021908-001	M-225	2021-04-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021908-002	M-225	2021-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021908-001	M-225	2021-04-26	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021908-002	M-225	2021-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021908-001	M-225	2021-04-26	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021908-002	M-225	2021-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021908-001	M-225	2021-04-26	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021908-002	M-225	2021-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021908-001	M-225	2021-04-26	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021908-002	M-225	2021-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021908-001	M-225	2021-04-26	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021908-002	M-225	2021-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021908-001	M-225	2021-04-26	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021908-002	M-225	2021-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021908-001	M-225	2021-04-26	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021908-002	M-225	2021-04-26	`ea99ee380514…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubiprostone	LUBIPROSTONE	Sun Pharmaceutical Industries, Inc.	f06d76d2-028a-629f-e053-2995a90a80f5	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Par Health USA, LLC	9d958b58-6c4f-4bb1-8660-cf5eac256440	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	SpecGx LLC	cdf79a5a-6857-4a32-8c54-8c435d1a7535	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Amitiza	LUBIPROSTONE	SpecGx LLC	164a2b47-0a52-4bb4-9e71-5342c2e951f4	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Dr. Reddy's Laboratories Inc.	006b8b6c-f0eb-4246-87da-67582984b0e4	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Golden State Medical Supply, Inc.	f4d506e0-1322-4fc4-e053-2995a90ac880	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
LUBIPROSTONE	LUBIPROSTONE	Natco Pharma USA LLC	10c7b62d-6c39-453c-8d9a-2f441725bc3b	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Asclemed USA, Inc.	f5653f3b-c3c8-487c-bc00-3770985aa5ee	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Direct Rx	2bd6f613-64d0-0291-e063-6294a90a0238	2025-01-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Advanced Rx of Tennessee, LLC	031149b9-c709-de1f-e063-6394a90a6d81	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Advanced Rx of Tennessee, LLC	031170a4-5f7d-b371-e063-6394a90ae21d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Quality Care Products, LLC	9bffe7c4-40f2-4490-a32f-15d525000928	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Amitiza	LUBIPROSTONE	Takeda Pharmaceuticals America, Inc.	d474ac6a-444d-4aa6-9986-24be6fcf811d	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908 ndc (package): 64764-240-40 ndc (product): 64764-240 ndc11 (package): 64764024040
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	4aed57d0-99d8-424e-a1c7-0cd8a31a66cf	2023-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	34c547c4-4c29-45a9-97c7-a828bf2ecde0	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	a368117c-0e80-4dbc-a0a7-9b88dbfeece3	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	ea61ffd1-0610-4264-b964-00a9f4485d36	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908

Additional Listing Data#

Finished product: Yes
Brand name base: Amitiza

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LUBIPROSTONE	24 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616578	Internal RxNorm lookup
617768	Internal RxNorm lookup
794639	Internal RxNorm lookup
794641	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d474ac6a-444d-4aa6-9986-24be6fcf811d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b517f14-6449-952f-8aaf-98f2ec9051d0	Product name	3	20251024
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
64764-240-10	Amitiza	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100	21
64764-240-40	Amitiza	1 in 1 CARTON	CAPSULE, GELATIN COATED	1	21
64764-240-40	Amitiza	4 in 1 CARTON	CAPSULE, GELATIN COATED	4	21
64764-240-60	Amitiza	60 in 1 BOTTLE	CAPSULE, GELATIN COATED	60	21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-240-60	EA - Each	64764-240	af136514-bbef-44de-8079-0753642e560d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
lubiprostone	ACTIVE INGREDIENT	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
lubiprostone	ACTIVE MOIETY	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
gelatin	INACTIVE INGREDIENT	2G86QN327L	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
medium-chain triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
sorbitol	INACTIVE INGREDIENT	506T60A25R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
water	INACTIVE INGREDIENT	059QF0KO0R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3170
lubiprostone	ACTIVE INGREDIENT	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
lubiprostone	ACTIVE MOIETY	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
D&C yellow no. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
gelatin	INACTIVE INGREDIENT	2G86QN327L	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
medium-chain triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
sorbitol	INACTIVE INGREDIENT	506T60A25R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
water	INACTIVE INGREDIENT	059QF0KO0R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	10
LUBIPROSTONE	ACTIVE INGREDIENT	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
LUBIPROSTONE	ACTIVE MOIETY	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [PHYSICIANS TOTAL CARE, INC.]	3
lubiprostone	ACTIVE INGREDIENT	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
lubiprostone	ACTIVE MOIETY	7662KG2R6K	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-240	AMITIZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	21	Current NDC, Legacy NDC, 4 package rows	20240302_d474ac6a-444d-4aa6-9986-24be6fcf811d.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7662KG2R6K	LUBIPROSTONE	136790-76-6	LUBIPROSTONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
617768	Amitiza 24 MCG Oral Capsule	PSN	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794641	Amitiza 8 MCG Oral Capsule	PSN	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
616578	lubiprostone 24 MCG Oral Capsule	PSN	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794639	lubiprostone 8 MCG Oral Capsule	PSN	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794641	lubiprostone 0.008 MG Oral Capsule [Amitiza]	SBD	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
617768	lubiprostone 0.024 MG Oral Capsule [Amitiza]	SBD	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794639	lubiprostone 0.008 MG Oral Capsule	SCD	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
616578	lubiprostone 0.024 MG Oral Capsule	SCD	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794641	Amitiza 0.008 MG Oral Capsule	SY	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
617768	Amitiza 0.024 MG Oral Capsule	SY	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
617768	Amitiza 24 MCG Oral Capsule	SY	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794641	Amitiza 8 MCG Oral Capsule	SY	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
616578	lubiprostone 24 MCG Oral Capsule	SY	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
794639	lubiprostone 8 MCG Oral Capsule	SY	d474ac6a-444d-4aa6-9986-24be6fcf811d	21
617768	Amitiza 24 MCG Oral Capsule	PSN	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794641	Amitiza 8 MCG Oral Capsule	PSN	222817c2-d4a6-43d0-8cbb-215f19acb198	3
616578	lubiprostone 24 MCG Oral Capsule	PSN	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794639	lubiprostone 8 MCG Oral Capsule	PSN	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794641	lubiprostone 0.008 MG Oral Capsule [Amitiza]	SBD	222817c2-d4a6-43d0-8cbb-215f19acb198	3
617768	lubiprostone 0.024 MG Oral Capsule [Amitiza]	SBD	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794639	lubiprostone 0.008 MG Oral Capsule	SCD	222817c2-d4a6-43d0-8cbb-215f19acb198	3
616578	lubiprostone 0.024 MG Oral Capsule	SCD	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794641	Amitiza 0.008 MG Oral Capsule	SY	222817c2-d4a6-43d0-8cbb-215f19acb198	3
617768	Amitiza 0.024 MG Oral Capsule	SY	222817c2-d4a6-43d0-8cbb-215f19acb198	3
617768	Amitiza 24 MCG Oral Capsule	SY	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794641	Amitiza 8 MCG Oral Capsule	SY	222817c2-d4a6-43d0-8cbb-215f19acb198	3
616578	lubiprostone 24 MCG Oral Capsule	SY	222817c2-d4a6-43d0-8cbb-215f19acb198	3
794639	lubiprostone 8 MCG Oral Capsule	SY	222817c2-d4a6-43d0-8cbb-215f19acb198	3
617768	Amitiza 24 MCG Oral Capsule	PSN	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2
616578	lubiprostone 24 MCG Oral Capsule	PSN	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2
617768	lubiprostone 0.024 MG Oral Capsule [Amitiza]	SBD	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2
616578	lubiprostone 0.024 MG Oral Capsule	SCD	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2
617768	Amitiza 0.024 MG Oral Capsule	SY	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2
617768	Amitiza 24 MCG Oral Capsule	SY	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2
616578	lubiprostone 24 MCG Oral Capsule	SY	1b632d92-a05b-42d3-88a6-b3e345d11fe4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-240-40	64764024040	4 CARTON in 1 CARTON (64764-240-40) > 1 BLISTER PACK in 1 CARTON > 4 CAPSULE, GELATIN COATED in 1 BLISTER PACK	4 carton	2006-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amitiza	Lake Erie Medical DBA Quality Care Products LLC	2025-01-14	HUMAN PRESCRIPTION DRUG LABEL	3177
Amitiza	Takeda Pharmaceuticals America, Inc. \| Sucampo Pharma Americas, LLC	2024-01-18	HUMAN PRESCRIPTION DRUG LABEL	21
Amitiza	Bryant Ranch Prepack	2020-10-16	HUMAN PRESCRIPTION DRUG LABEL	4
Amitiza	Carilion Materials Management	2013-04-25	HUMAN PRESCRIPTION DRUG LABEL	2
Amitiza	Physicians Total Care, Inc.	2010-05-18	HUMAN PRESCRIPTION DRUG LABEL	3