Lubiprostone

Product NDC: 71205-834
11-digit product format: 712050834
Labeler code: 71205
Product ID: 71205-834_a368117c-0e80-4dbc-a0a7-9b88dbfeece3
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.

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
2026-08-01 22:54:32	2026-06	N021908-001	AMITIZA	24MCG	CAPSULE / ORAL	AB	RLD, RS	2006-01-31	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-002	AMITIZA	8MCG	CAPSULE / ORAL	AB	RLD	2008-04-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N021908-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021908-001	8338639	2027-01-23	Drug product	2012-12-20	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-001	8779187	2027-01-23	Drug product	2014-08-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-001	8026393	2027-10-25	Drug product	2011-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-002	8338639	2027-01-23	Drug product		`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-002	8779187	2027-01-23	Drug product	2014-08-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021908-002	8026393	2027-10-25	Drug product		`a50c72e98297…`

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 ndc (product): 71205-834
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	ea61ffd1-0610-4264-b964-00a9f4485d36	2023-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021908 application number: NDA021908

Additional Listing Data#

Finished product: Yes
Brand name base: 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
a368117c-0e80-4dbc-a0a7-9b88dbfeece3	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
71205-834-00	Lubiprostone	100 in 1 BOTTLE	CAPSULE, GELATIN COATED	100	1
71205-834-11	Lubiprostone	1000 in 1 BOTTLE	CAPSULE, GELATIN COATED	1000	1
71205-834-30	Lubiprostone	30 in 1 BOTTLE	CAPSULE, GELATIN COATED	30	1
71205-834-55	Lubiprostone	500 in 1 BOTTLE	CAPSULE, GELATIN COATED	500	1
71205-834-60	Lubiprostone	60 in 1 BOTTLE	CAPSULE, GELATIN COATED	60	1
71205-834-64	Lubiprostone	240 in 1 BOTTLE	CAPSULE, GELATIN COATED	240	1
71205-834-67	Lubiprostone	270 in 1 BOTTLE	CAPSULE, GELATIN COATED	270	1
71205-834-72	Lubiprostone	120 in 1 BOTTLE	CAPSULE, GELATIN COATED	120	1
71205-834-78	Lubiprostone	180 in 1 BOTTLE	CAPSULE, GELATIN COATED	180	1
71205-834-90	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
71205-834-00	EA - Each	71205-834	0f0763ca-be2f-48e1-9a3f-b10e5baac479	1	2023-09-05
71205-834-11	EA - Each	71205-834	aaaf0c30-9c19-4e41-8d9d-088ebc814863	1	2023-09-05
71205-834-30	EA - Each	71205-834	dccb4d10-faf8-4883-ac59-8a9d207e2a2f	1	2023-09-05
71205-834-55	EA - Each	71205-834	d74f8337-989e-48a6-9ed2-85e9a73ddd4c	1	2023-09-05
71205-834-60	EA - Each	71205-834	b4cdb378-03ca-41f7-9124-470b9a86e5fa	1	2023-09-05
71205-834-64	EA - Each	71205-834	e392e80b-b8e8-4440-bc75-957b8b840962	1	2023-09-05
71205-834-67	EA - Each	71205-834	60260bcc-90bb-4dae-ab22-5010ae8d5377	1	2023-09-05
71205-834-72	EA - Each	71205-834	1175b461-f20c-44ea-b191-75f5f640bddf	1	2023-09-05
71205-834-78	EA - Each	71205-834	8c67dee0-ad9c-4a91-8a89-ceeb780ce40a	1	2023-09-05
71205-834-90	EA - Each	71205-834	7af563c3-a24c-4a2f-ad3e-1d60bac4aa84	1	2023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-834	LUBIPROSTONE CAPSULE, GELATIN COATED [PROFICIENT RX LP]	1	Current NDC, 10 package rows	20230819_a368117c-0e80-4dbc-a0a7-9b88dbfeece3.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	a368117c-0e80-4dbc-a0a7-9b88dbfeece3	1
616578	lubiprostone 0.024 MG Oral Capsule	SCD	a368117c-0e80-4dbc-a0a7-9b88dbfeece3	1
616578	lubiprostone 24 MCG Oral Capsule	SY	a368117c-0e80-4dbc-a0a7-9b88dbfeece3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71205-834-00	71205083400	100 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-00)	2023-08-18	No	No	Current
71205-834-11	71205083411	1000 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-11)	2023-08-18	No	No	Current
71205-834-30	71205083430	30 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-30)	2023-08-18	No	No	Current
71205-834-55	71205083455	500 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-55)	2023-08-18	No	No	Current
71205-834-60	71205083460	60 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-60)	2023-08-18	No	No	Current
71205-834-64	71205083464	240 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-64)	2023-08-18	No	No	Current
71205-834-67	71205083467	270 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-67)	2023-08-18	No	No	Current
71205-834-72	71205083472	120 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-72)	2023-08-18	No	No	Current
71205-834-78	71205083478	180 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-78)	2023-08-18	No	No	Current
71205-834-90	71205083490	90 CAPSULE, GELATIN COATED in 1 BOTTLE (71205-834-90)	2023-08-18	No	No	Current