Intuniv

Product NDC: 54092-517
11-digit product format: 540920517
Labeler code: 54092
Product ID: 54092-517_448b4d80-7441-4a2f-839f-c61052d6e83a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Takeda Pharmaceuticals America, Inc.
Application: NDA022037
Marketing category: NDA
Marketing start: 2009-09-02
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 3 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	54092-517	54092-517-03	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 · 12 matching rows.

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

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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022037-001	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02
N022037-002	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02
N022037-003	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02
N022037-004	INTUNIV	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022037-001	AB
N022037-002	AB
N022037-003	AB
N022037-004	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 5 · 164 observed 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
2026-02-19 14:30 UTC	2026-02	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022037-001	INTUNIV	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-002	INTUNIV	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-003	INTUNIV	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2009-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-004	INTUNIV	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2009-09-02	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N022037-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022037-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022037-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022037-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022037-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022037-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022037-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022037-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022037-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022037-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022037-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022037-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022037-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 228 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-001	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-002	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-003	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-004	6811794	2022-07-04	U-494	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022037-001	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-002	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-003	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-004	6811794	2022-07-04	U-494	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022037-001	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-002	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-003	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-004	6811794	2022-07-04	U-494	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-001	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-002	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-003	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6287599	2020-12-20		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6287599*PED	2021-06-20		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6811794	2022-07-04	U-494	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022037-004	6811794*PED	2023-01-04		Pediatric extension	`74a2ff9319b5…`

Additional Listing Data#

Finished product: Yes
Brand name base: Intuniv
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUANFACINE HYDROCHLORIDE	3 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PML56A160O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
862006	Internal RxNorm lookup
862010	Internal RxNorm lookup
862013	Internal RxNorm lookup
862015	Internal RxNorm lookup
862019	Internal RxNorm lookup
862021	Internal RxNorm lookup
862025	Internal RxNorm lookup
862027	Internal RxNorm lookup
1092566	Internal RxNorm lookup
1092567	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
b972af81-3a37-40be-9fe1-3ddf59852528	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
44b80df7-57c9-56d4-c87a-f0d57d327460	Product name	9	20260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0	Product name	3	20230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54092-517-02	Intuniv	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		44
54092-517-03	Intuniv	7 in 1 BOTTLE	TABLET, EXTENDED RELEASE	7		44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-517-02	EA - Each	54092-517	765d54ae-93ba-410f-bc99-43098154bebf	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUANFACINE HYDROCHLORIDE	ACTIVE INGREDIENT	PML56A160O	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
GUANFACINE	ACTIVE MOIETY	30OMY4G3MK	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
FUMARIC ACID	INACTIVE INGREDIENT	88XHZ13131	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [SHIRE US MANUFACTURING INC.]	27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-517	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE INTUNIV (GUANFACINE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	42	Current NDC, Legacy NDC, 2 package rows	20250511_b972af81-3a37-40be-9fe1-3ddf59852528.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
Intuniv	GUANFACINE	Takeda Pharmaceuticals America, Inc.	b972af81-3a37-40be-9fe1-3ddf59852528	2025-06-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022037 application number: NDA022037 ndc (product): 54092-517

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
PML56A160O	GUANFACINE HYDROCHLORIDE	29110-48-3	GUANFACINE HYDROCHLORIDE
30OMY4G3MK	GUANFACINE	29110-47-2	guanfacine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092567	{7 (24 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]) } Pack [Intuniv Kit 7/7]	BPCK	b972af81-3a37-40be-9fe1-3ddf59852528	44
1092566	{7 (24 HR guanfacine 1 MG Extended Release Oral Tablet) / 7 (24 HR guanfacine 2 MG Extended Release Oral Tablet) } Pack	GPCK	b972af81-3a37-40be-9fe1-3ddf59852528	44
862006	guanFACINE 1 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
1092566	guanFACINE 1 MG 24HR Extended Release Oral Tablet (7) / guanFACINE 2 MG 24HR Extended Release Oral Tablet (7) Pack	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862019	guanFACINE 3 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862025	guanFACINE 4 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862010	intuniv 1 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862015	intuniv 2 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862021	intuniv 3 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862027	intuniv 4 MG 24HR Extended Release Oral Tablet	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
1092567	Intuniv Kit 7/7	PSN	b972af81-3a37-40be-9fe1-3ddf59852528	44
862010	24 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]	SBD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862015	24 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]	SBD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862021	24 HR guanfacine 3 MG Extended Release Oral Tablet [Intuniv]	SBD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862027	24 HR guanfacine 4 MG Extended Release Oral Tablet [Intuniv]	SBD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862019	24 HR guanfacine 3 MG Extended Release Oral Tablet	SCD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862025	24 HR guanfacine 4 MG Extended Release Oral Tablet	SCD	b972af81-3a37-40be-9fe1-3ddf59852528	44
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862010	Intuniv 1 MG (guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862010	Intuniv 1 MG 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862015	Intuniv 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862015	Intuniv 2 MG 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862021	Intuniv 3 MG (guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862021	Intuniv 3 MG 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862027	Intuniv 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
862027	Intuniv 4 MG 24 HR Extended Release Oral Tablet	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44
1092567	Intuniv Kit 7/7	SY	b972af81-3a37-40be-9fe1-3ddf59852528	44

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-517-02	54092051702	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (54092-517-02)	2009-09-02	0000-00-00	No	No	Current
54092-517-03	54092051703	7 in 1 BOTTLE					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Intuniv	Takeda Pharmaceuticals America, Inc. \| Industriale Chimica SRL \| Catalent Pharma Solutions, LLC \| Mayne Pharma International Pty Ltd. \| Patheon Manufacturing Services LLC \| Quimica Sintetica S.A. \| Sharp Packaging Services, LLC \| Pharmazell (India) Private Limited	2025-06-23	HUMAN PRESCRIPTION DRUG LABEL	44