Irbesartan

Product NDC: 68180-410
11-digit product format: 681800410
Labeler code: 68180
Product ID: 68180-410_58ed0a7a-78d3-47e3-95f6-ee4d1dd128bf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Irbesartan
Dosage form: TABLET
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA201531
Marketing category: ANDA
Marketing start: 2012-10-23
Marketing end: 0000-00-00
Substance: IRBESARTAN
Active strength: 75 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68180-410		D	Discontinued by firm	2026-08-11
excluded package	package	68180-410	68180-410-06	D	Discontinued by firm	2026-08-11
excluded package	package	68180-410	68180-410-09	D	Discontinued by firm	2026-08-11

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-410-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-410-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-410-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-410-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-410-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-410-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-410-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-410-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-410-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-410-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-410-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-410-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-410-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-410-06	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-410-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-410-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-410-09	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-410-06	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-410-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-410-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-410-09	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-410-06	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-410-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-410-06	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A201531-001	IRBESARTAN	IRBESARTAN	75MG	TABLET / ORAL	2012-10-15
A201531-002	IRBESARTAN	IRBESARTAN	150MG	TABLET / ORAL	2012-10-15
A201531-003	IRBESARTAN	IRBESARTAN	300MG	TABLET / ORAL	2012-10-15

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 4 · 123 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	A201531-001	IRBESARTAN	75MG	TABLET / ORAL		2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201531-002	IRBESARTAN	150MG	TABLET / ORAL		2012-10-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201531-003	IRBESARTAN	300MG	TABLET / ORAL		2012-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201531-001	IRBESARTAN	75MG	TABLET / ORAL		2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201531-002	IRBESARTAN	150MG	TABLET / ORAL		2012-10-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201531-003	IRBESARTAN	300MG	TABLET / ORAL		2012-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201531-002	IRBESARTAN	150MG	TABLET / ORAL	AB	2012-10-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201531-003	IRBESARTAN	300MG	TABLET / ORAL	AB	2012-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201531-001	IRBESARTAN	75MG	TABLET / ORAL	AB	2012-10-15	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A201531-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201531-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201531-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201531-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201531-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201531-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201531-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201531-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201531-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201531-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201531-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201531-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201531-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201531-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201531-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201531-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201531-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201531-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201531-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201531-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201531-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201531-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201531-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201531-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201531-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201531-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201531-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201531-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201531-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201531-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201531-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201531-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201531-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201531-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201531-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A201531-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201531-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201531-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201531-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201531-001	AB	1	`5d02ea3f76ae…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
34942a29-de4f-d63c-7755-ba18fe1411a0	Product name	6	20180619
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68180-410-06	Irbesartan	30 in 1 BOTTLE	TABLET	30		17
68180-410-09	Irbesartan	90 in 1 BOTTLE	TABLET	90		17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-410-06	EA - Each	68180-410	a30e6baf-e7a6-465e-933e-851605f0c5e3	1	2013-02-13
68180-410-09	EA - Each	68180-410	2cc8c86a-5156-4c7a-b773-99a2aea1b242	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IRBESARTAN	ACTIVE INGREDIENT	J0E2756Z7N	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
IRBESARTAN	ACTIVE MOIETY	J0E2756Z7N	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68180-410	IRBESARTAN TABLET [LUPIN PHARMACEUTICALS, INC.]	17	Legacy NDC, 2 package rows	20231129_a7c093c2-3eef-4956-8a14-c36aada0304f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Irbesartan	IRBESARTAN	Lupin Pharmaceuticals, Inc.	a7c093c2-3eef-4956-8a14-c36aada0304f	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201531 application number: ANDA201531 ndc (product): 68180-410

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J0E2756Z7N	IRBESARTAN	138402-11-6	IRBESARTAN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200095	irbesartan 150 MG Oral Tablet	PSN	a7c093c2-3eef-4956-8a14-c36aada0304f	17
200096	irbesartan 300 MG Oral Tablet	PSN	a7c093c2-3eef-4956-8a14-c36aada0304f	17
200094	irbesartan 75 MG Oral Tablet	PSN	a7c093c2-3eef-4956-8a14-c36aada0304f	17
200095	irbesartan 150 MG Oral Tablet	SCD	a7c093c2-3eef-4956-8a14-c36aada0304f	17
200096	irbesartan 300 MG Oral Tablet	SCD	a7c093c2-3eef-4956-8a14-c36aada0304f	17
200094	irbesartan 75 MG Oral Tablet	SCD	a7c093c2-3eef-4956-8a14-c36aada0304f	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68180-410-06	68180041006	30 TABLET in 1 BOTTLE (68180-410-06)	30 tablet	2012-10-23	0000-00-00	No	No	Current
68180-410-09	68180041009	90 TABLET in 1 BOTTLE (68180-410-09)	90 tablet	2012-10-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Irbesartan	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2023-11-22	HUMAN PRESCRIPTION DRUG LABEL	17