Amitza

Product NDC: 72189-410
Requested package NDC: 72189-410-60
11-digit product format: 721890410
Labeler code: 72189
Product ID: 72189-410_2c4cfec2-fedf-e007-e063-6294a90a3cf9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lubiprostone
Dosage form: CAPSULE, GELATIN COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA209920
Marketing category: ANDA
Marketing start: 2023-01-12
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72189-410	72189-410-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72189-410	72189-410-60	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 64 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	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…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209920-001	LUBIPROSTONE	8MCG	CAPSULE / ORAL	AB	2022-01-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209920-002	LUBIPROSTONE	24MCG	CAPSULE / ORAL	AB	2022-01-18	`1c564ffb4f44…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	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…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209920-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209920-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209920-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209920-002	AB	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: Amitza
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 SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f2121338-9586-161d-e053-2995a90af908	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
72189-410-60	Amitza	60 in 1 BOTTLE	CAPSULE, GELATIN COATED	60		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72189-410-60	EA - Each	72189-410	9b8c8794-6b8d-4f7a-989c-73f848a2c720	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72189-410	AMITZA (LUBIPROSTONE) CAPSULE, GELATIN COATED [DIRECT_RX]	2	Current NDC, Legacy NDC, 1 package rows	20250123_f2121338-9586-161d-e053-2995a90af908.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 · 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
Amitza	LUBIPROSTONE	Direct_Rx	f2121338-9586-161d-e053-2995a90af908	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209920 application number: ANDA209920 ndc (package): 72189-410-60 ndc (product): 72189-410 ndc11 (package): 72189041060
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72189-410-60	72189041060	60 CAPSULE, GELATIN COATED in 1 BOTTLE (72189-410-60)	2023-01-12	0000-00-00	No	No	Current