Lubiprostone

Product NDC: 71205-831
11-digit product format: 712050831
Labeler code: 71205
Product ID: 71205-831_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lubiprostone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: NDA021908
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2023-01-01
Substance: LUBIPROSTONE
Active strength: 8 ug/1
Pharmacologic classes: Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Lubiprostone
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LUBIPROSTONE	8 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
794639	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
4aed57d0-99d8-424e-a1c7-0cd8a31a66cf	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-831-00	Lubiprostone	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100	1
71205-831-11	Lubiprostone	1000 in 1 BOTTLE	CAPSULE, GELATIN COATED	1000	1
71205-831-30	Lubiprostone	30 in 1 BOTTLE	CAPSULE, GELATIN COATED	30	1
71205-831-55	Lubiprostone	500 in 1 BOTTLE	CAPSULE, GELATIN COATED	500	1
71205-831-60	Lubiprostone	60 in 1 BOTTLE	CAPSULE, GELATIN COATED	60	1
71205-831-64	Lubiprostone	240 in 1 BOTTLE	CAPSULE, GELATIN COATED	240	1
71205-831-67	Lubiprostone	270 in 1 BOTTLE	CAPSULE, GELATIN COATED	270	1
71205-831-72	Lubiprostone	120 in 1 BOTTLE	CAPSULE, GELATIN COATED	120	1
71205-831-78	Lubiprostone	180 in 1 BOTTLE	CAPSULE, GELATIN COATED	180	1
71205-831-90	Lubiprostone	90 in 1 BOTTLE	CAPSULE, GELATIN COATED	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-831	LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]	1	Current NDC, 10 package rows	20231019_4aed57d0-99d8-424e-a1c7-0cd8a31a66cf.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
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 ndc (product): 71205-831
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
794639	lubiprostone 8 MCG Oral Capsule	PSN	4aed57d0-99d8-424e-a1c7-0cd8a31a66cf	1
794639	lubiprostone 0.008 MG Oral Capsule	SCD	4aed57d0-99d8-424e-a1c7-0cd8a31a66cf	1
794639	lubiprostone 8 MCG Oral Capsule	SY	4aed57d0-99d8-424e-a1c7-0cd8a31a66cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71205-831-00	71205083100	100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-00)	2023-10-18	No	No	Current
71205-831-11	71205083111	1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-11)	2023-10-18	No	No	Current
71205-831-30	71205083130	30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-30)	2023-10-18	No	No	Current
71205-831-55	71205083155	500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-55)	2023-10-18	No	No	Current
71205-831-60	71205083160	60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-60)	2023-10-18	No	No	Current
71205-831-64	71205083164	240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-64)	2023-10-18	No	No	Current
71205-831-67	71205083167	270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-67)	2023-10-18	No	No	Current
71205-831-72	71205083172	120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-72)	2023-10-18	No	No	Current
71205-831-78	71205083178	180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-78)	2023-10-18	No	No	Current
71205-831-90	71205083190	90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-831-90)	2023-10-18	No	No	Current