Lubiprostone

Product NDC: 71205-832
11-digit product format: 712050832
Labeler code: 71205
Product ID: 71205-832_ea61ffd1-0610-4264-b964-00a9f4485d36
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: 24 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 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 2 · 66 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
2024-11-08 22:44 UTC · 2 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 · 2 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…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL		RLD, RS	2006-01-31	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL		RLD	2008-04-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL	AB	RLD, RS	2006-01-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL	AB	RLD	2008-04-29	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 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…`
2024-02-18 07:12 UTC	2024-02	N021908-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N021908-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021908-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N021908-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021908-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021908-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021908-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021908-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021908-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021908-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021908-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021908-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021908-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021908-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021908-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021908-002	AB	1	`3bdfa0b2c4d7…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 558 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-001	8779187	2027-01-23		Drug product	2014-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-001	8026393	2027-10-25		Drug product	2011-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-002	7795312	2024-09-17	U-1085			`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-002	8748481	2025-09-01	U-1519		2014-06-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-002	8338639	2027-01-23		Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-002	8779187	2027-01-23		Drug product	2014-08-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 2 captures of this ZIP	2024-11	N021908-002	8026393	2027-10-25		Drug product		`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-001	8779187	2027-01-23		Drug product	2014-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-001	8026393	2027-10-25		Drug product	2011-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-002	7795312	2024-09-17	U-1085			`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-002	8748481	2025-09-01	U-1519		2014-06-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-002	8338639	2027-01-23		Drug product		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-002	8779187	2027-01-23		Drug product	2014-08-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021908-002	8026393	2027-10-25		Drug product		`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-001	8779187	2027-01-23		Drug product	2014-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-001	8026393	2027-10-25		Drug product	2011-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-002	7795312	2024-09-17	U-1085			`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-002	8748481	2025-09-01	U-1519		2014-06-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-002	8338639	2027-01-23		Drug product		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-002	8779187	2027-01-23		Drug product	2014-08-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021908-002	8026393	2027-10-25		Drug product		`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-001	8779187	2027-01-23		Drug product	2014-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-001	8026393	2027-10-25		Drug product	2011-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-002	7795312	2024-09-17	U-1085			`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-002	8748481	2025-09-01	U-1519		2014-06-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-002	8338639	2027-01-23		Drug product		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-002	8779187	2027-01-23		Drug product	2014-08-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021908-002	8026393	2027-10-25		Drug product		`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021908-001	8748481	2025-09-01	U-1520		2014-06-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021908-001	8338639	2027-01-23		Drug product	2012-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021908-001	8779187	2027-01-23		Drug product	2014-08-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021908-001	8026393	2027-10-25		Drug product	2011-10-26	`1e350fbaab3a…`

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
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 ndc (product): 71205-832

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616578	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
ea61ffd1-0610-4264-b964-00a9f4485d36	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
71205-832-00	Lubiprostone	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100	1
71205-832-11	Lubiprostone	1000 in 1 BOTTLE	CAPSULE, GELATIN COATED	1000	1
71205-832-30	Lubiprostone	30 in 1 BOTTLE	CAPSULE, GELATIN COATED	30	1
71205-832-55	Lubiprostone	500 in 1 BOTTLE	CAPSULE, GELATIN COATED	500	1
71205-832-60	Lubiprostone	60 in 1 BOTTLE	CAPSULE, GELATIN COATED	60	1
71205-832-64	Lubiprostone	240 in 1 BOTTLE	CAPSULE, GELATIN COATED	240	1
71205-832-67	Lubiprostone	270 in 1 BOTTLE	CAPSULE, GELATIN COATED	270	1
71205-832-72	Lubiprostone	120 in 1 BOTTLE	CAPSULE, GELATIN COATED	120	1
71205-832-78	Lubiprostone	180 in 1 BOTTLE	CAPSULE, GELATIN COATED	180	1
71205-832-90	Lubiprostone	90 in 1 BOTTLE	CAPSULE, GELATIN COATED	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-832-00	EA - Each	71205-832	eac034c2-51b3-47af-8fae-4923355fcf3a	1	2023-09-05
71205-832-11	EA - Each	71205-832	2f411c63-95cb-401f-842e-5d963e74ddd4	1	2023-09-05
71205-832-30	EA - Each	71205-832	eb15ec60-28a9-4919-9a21-95899048a13b	1	2023-09-05
71205-832-55	EA - Each	71205-832	d168ca27-02e0-4d65-a40e-a8c80f9c409e	1	2023-09-05
71205-832-60	EA - Each	71205-832	44c8c732-1fa6-4121-98db-bb15f626472c	1	2023-09-05
71205-832-64	EA - Each	71205-832	376bc324-dee6-490d-834c-f863c5365b71	1	2023-09-05
71205-832-67	EA - Each	71205-832	8916e1e0-7b85-4aae-9917-92ff480ecb40	1	2023-09-05
71205-832-72	EA - Each	71205-832	f2d3aed4-d2c6-4726-a4fc-483ad840a316	1	2023-09-05
71205-832-78	EA - Each	71205-832	b81a681e-b81f-4683-8701-fa58e21382fe	1	2023-09-05
71205-832-90	EA - Each	71205-832	bf0591e9-adc4-43c4-91c0-bb47d03bab0f	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-832	LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]	1	Current NDC, 10 package rows	20230819_ea61ffd1-0610-4264-b964-00a9f4485d36.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
616578	lubiprostone 24 MCG Oral Capsule	PSN	ea61ffd1-0610-4264-b964-00a9f4485d36	1
616578	lubiprostone 0.024 MG Oral Capsule	SCD	ea61ffd1-0610-4264-b964-00a9f4485d36	1
616578	lubiprostone 24 MCG Oral Capsule	SY	ea61ffd1-0610-4264-b964-00a9f4485d36	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71205-832-00	71205083200	100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-00)	2023-08-18	No	No	Current
71205-832-11	71205083211	1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-11)	2023-08-18	No	No	Current
71205-832-30	71205083230	30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-30)	2023-08-18	No	No	Current
71205-832-55	71205083255	500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-55)	2023-08-18	No	No	Current
71205-832-60	71205083260	60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-60)	2023-08-18	No	No	Current
71205-832-64	71205083264	240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-64)	2023-08-18	No	No	Current
71205-832-67	71205083267	270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-67)	2023-08-18	No	No	Current
71205-832-72	71205083272	120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-72)	2023-08-18	No	No	Current
71205-832-78	71205083278	180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-78)	2023-08-18	No	No	Current
71205-832-90	71205083290	90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-832-90)	2023-08-18	No	No	Current