Amitiza

Product NDC: 35356-500
Requested package NDC: 35356-500-60
11-digit product format: 353560500
Labeler code: 35356
Product ID: 35356-500_baf8d3dc-b57f-4bcf-8a75-70ccd3f4e03d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lubiprostone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Lake Erie Medical DBA Quality Care Products LLC
Application: NDA021908
Marketing category: NDA
Marketing start: 2011-06-01
Marketing end: 0000-00-00
Substance: LUBIPROSTONE
Active strength: 24 ug/1
Pharmacologic classes: Chloride Channel Activator [EPC],Chloride Channel Activators [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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	35356-500	35356-500-60	D	Discontinued by firm		2026-08-17

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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
2026-08-18 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…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021908-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021908-002	AB	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 629 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
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…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
35356-500-60	2025-01-14	C162847	48780-1	d6a99b39-5032-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 2006
35356-500-60	2022-01-28	C162847	48780-1	d6a99b39-5032-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use AMITIZA safely and effectively. See full prescribing information for AMITIZA. AMITIZA (lubiprostone) capsule, gelatin coated for oral use Initial U.S. Approval: 2006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
35356-500-60	EA - Each	35356-500	89207e83-860d-4d07-a0b2-2e01ea694abc	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

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
35356-500-60	35356050060	60 CAPSULE, GELATIN COATED in 1 BOTTLE (35356-500-60)	2011-06-01	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