Lubiprostone

Product NDC: 42291-476
Requested package NDC: 42291-476-60
11-digit product format: 422910476
Labeler code: 42291
Product ID: 42291-476_f1763c5a-5f35-fac0-e053-2995a90a038a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lubiprostone
Dosage form: CAPSULE
Route: ORAL
Labeler: AvKARE
Application: ANDA209450
Marketing category: ANDA
Marketing start: 2023-01-04
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: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	42291-476	42291-476-60	I	Inactivated by FDA		2026-08-03

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
A209450-001	LUBIPROSTONE	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB		2021-11-30
A209450-002	LUBIPROSTONE	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB		2021-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209450-001	AB
A209450-002	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 · 66 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
2026-02-19 14:30 UTC	2026-02	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL		2021-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL		2021-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL		2021-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL		2021-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209450-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2021-11-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209450-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2021-11-30	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209450-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209450-002	AB	1	`011fe1cb6892…`
2025-08-23 18:47 UTC	2025-08	A209450-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209450-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209450-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209450-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209450-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209450-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209450-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209450-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209450-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209450-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209450-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209450-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209450-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209450-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209450-002	AB	1	`8072bd15b7f6…`
2022-04-08 23:34 UTC	2022-04	A209450-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209450-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209450-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209450-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209450-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209450-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209450-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209450-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209450-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209450-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209450-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209450-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209450-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209450-002	AB	1	`ea1830bbd6c7…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b517f14-6449-952f-8aaf-98f2ec9051d0	Product name	3	20251024

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42291-476-60	2026-01-29	C162847	48780-1	49896155-c6e8-586f-e063-e6dba90add90	Lubiprostone Capsules Rx Only These highlights do not include all the information needed to use LUBIPROSTONE CAPSULES, safely and effectively. See full prescribing information for LUBIPROSTONE CAPSULES. Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-476-60	Lubiprostone	60 in 1 BOTTLE	CAPSULE	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-476-60	EA - Each	42291-476	92e8ce9b-0051-4e60-91eb-8090fd55993b	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-476	LUBIPROSTONE CAPSULE [AVKARE]	2	Legacy NDC, 1 package rows	20230325_f1763c5a-5f36-fac0-e053-2995a90a038a.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	f1763c5a-5f36-fac0-e053-2995a90a038a	2
794639	lubiprostone 8 MCG Oral Capsule	PSN	f1763c5a-5f36-fac0-e053-2995a90a038a	2
794639	lubiprostone 0.008 MG Oral Capsule	SCD	f1763c5a-5f36-fac0-e053-2995a90a038a	2
616578	lubiprostone 0.024 MG Oral Capsule	SCD	f1763c5a-5f36-fac0-e053-2995a90a038a	2
616578	lubiprostone 24 MCG Oral Capsule	SY	f1763c5a-5f36-fac0-e053-2995a90a038a	2
794639	lubiprostone 8 MCG Oral Capsule	SY	f1763c5a-5f36-fac0-e053-2995a90a038a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-476-60	42291047660	60 CAPSULE in 1 BOTTLE (42291-476-60)	60 capsule	2023-01-04	0000-00-00	No	No	Current