Lubiprostone

Product NDC: 60687-827
Requested package NDC: 60687-827-32
11-digit product format: 606870827
Labeler code: 60687
Product ID: 60687-827_4dc7a17c-dac7-1755-e063-6294a90aa2e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lubiprostone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA209920
Marketing category: ANDA
Marketing start: 2025-11-26
Substance: LUBIPROSTONE
Active strength: 24 ug/1
Pharmacologic classes: Chloride Channel Activator [EPC], Chloride Channel Activators [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A209920-001	LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB		2022-01-18
A209920-002	LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB		2022-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209920-001	AB
A209920-002	AB

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 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209920-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209920-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209920-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209920-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209920-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209920-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209920-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209920-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209920-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209920-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209920-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209920-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209920-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209920-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209920-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209920-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209920-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209920-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209920-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209920-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209920-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209920-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209920-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209920-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209920-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209920-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209920-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209920-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209920-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209920-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209920-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209920-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209920-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209920-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209920-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209920-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209920-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209920-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209920-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209920-002	AB	1	`bb7c543d1eb4…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Lubiprostone
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
616578	Internal RxNorm lookup
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
3014dd6d-9c05-479d-b79d-7a49f78a1ce5	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	Strength	SPL version
60687-827-32	Lubiprostone	20 in 1 CARTON	CAPSULE, GELATIN COATED	20		4
60687-827-33	Lubiprostone	1 in 1 BLISTER PACK	CAPSULE, GELATIN COATED	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60687-827-32	EA - Each	60687-827	fa16de18-f525-44ba-9c02-4674d761820d	1	2025-12-16
60687-827-33	EA - Each	60687-827	055501df-cbf0-4ae1-a0ec-cfe9c3e2aeb7	1	2025-12-16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lubiprostone	LUBIPROSTONE	Proficient Rx LP	5fd683a5-87ff-42b8-a8c8-fff81625f67f	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209920 application number: ANDA209920
Lubiprostone	LUBIPROSTONE	American Health Packaging	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209920 application number: ANDA209920 ndc (package): 60687-827-32 ndc (product): 60687-827 ndc11 (package): 60687082732
Amitza	LUBIPROSTONE	Direct_Rx	f2121338-9586-161d-e053-2995a90af908	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209920 application number: ANDA209920
Lubiprostone	LUBIPROSTONE	Teva Pharmaceuticals, Inc.	e17b521e-2c25-4bef-82f9-7916fa79bca4	2022-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209920 application number: ANDA209920

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	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	4
794639	lubiprostone 8 MCG Oral Capsule	PSN	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	4
794639	lubiprostone 0.008 MG Oral Capsule	SCD	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	4
616578	lubiprostone 0.024 MG Oral Capsule	SCD	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	4
616578	lubiprostone 24 MCG Oral Capsule	SY	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	4
794639	lubiprostone 8 MCG Oral Capsule	SY	3014dd6d-9c05-479d-b79d-7a49f78a1ce5	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60687-827-32	60687082732	20 BLISTER PACK in 1 CARTON (60687-827-32) / 1 CAPSULE, GELATIN COATED in 1 BLISTER PACK (60687-827-33)	20 blister pack	2025-11-26	No	No	Current