Intuniv

Product NDC: 64725-0513
11-digit product format: 647250513
Labeler code: 64725
Product ID: 64725-0513_6d3d53d5-10d9-46a7-a251-f1eb1a2ffeeb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: TYA Pharmaceuticals
Application: NDA022037
Marketing category: NDA
Marketing start: 2009-09-02
Marketing end: 0000-00-00
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	64725-0513		I	Inactivated by FDA		2026-08-11
excluded package	package	64725-0513	64725-0513-1	I	Inactivated by FDA		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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64725-0513-1	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64725-0513-1	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64725-0513-1	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64725-0513-1	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64725-0513-1	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64725-0513-1	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64725-0513-1	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64725-0513-1	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64725-0513-1	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64725-0513-1	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64725-0513-1	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64725-0513-1	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64725-0513-1	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64725-0513-1	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64725-0513-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64725-0513-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64725-0513-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64725-0513-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64725-0513-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64725-0513-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	64725-0513-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	64725-0513-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-0513-1	2020-01-31	C162847	48780-1	9d75b9d0-bd13-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use INTUNIV safely and effectively. See full prescribing information for INTUNIV . INTUNIV (guanfacine) extended-release tablets, for oral use Initial U.S. Approval: 1986 ® ® ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-0513-1	Intuniv	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUANFACINE HYDROCHLORIDE	ACTIVE INGREDIENT	PML56A160O	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
GUANFACINE	ACTIVE MOIETY	30OMY4G3MK	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
FUMARIC ACID	INACTIVE INGREDIENT	88XHZ13131	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
HYPROMELLOSE 2208 (15000 MPA.S)	INACTIVE INGREDIENT	Z78RG6M2N2	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-0513	INTUNIV (GUANFACINE) TABLET, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20141019_1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47.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

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
862006	guanFACINE 1 MG 24HR Extended Release Oral Tablet	PSN	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862010	intuniv 1 MG 24HR Extended Release Oral Tablet	PSN	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862015	intuniv 2 MG 24HR Extended Release Oral Tablet	PSN	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862010	24 HR guanfacine 1 MG Extended Release Oral Tablet [Intuniv]	SBD	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862015	24 HR guanfacine 2 MG Extended Release Oral Tablet [Intuniv]	SBD	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862010	Intuniv 1 MG (guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862010	Intuniv 1 MG 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862015	Intuniv 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4
862015	Intuniv 2 MG 24 HR Extended Release Oral Tablet	SY	1bb3fac5-11e8-4d1c-a5e4-2520abcdeb47	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
64725-0513-1	64725051301	100 in 1 BOTTLE	Historical