Amitiza

Product NDC: 64764-240
Requested package NDC: 64764-240-10
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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	64764-240-10	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64764-240	64764-240-10	D	Discontinued by firm	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64764-240	64764-240-10	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	64764-240-10	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	64764-240-10	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	64764-240-10	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…`

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

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 · 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): 64764-240-10 ndc (product): 64764-240 ndc11 (package): 64764024010
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

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	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-240-10	64764024010	100 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-10)	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