Guanfacine

Product NDC: 24658-731
11-digit product format: 246580731
Labeler code: 24658
Product ID: 24658-731_7ea99ece-0ef4-6bd1-e053-2a91aa0a7e8c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Guanfacine
Dosage form: TABLET
Route: ORAL
Labeler: PuraCap Laboratories LLC dba Blu Pharmaceuticals
Application: ANDA074673
Marketing category: ANDA
Marketing start: 2016-11-14
Marketing end: 0000-00-00
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	24658-731		D	Discontinued by firm		2026-08-17
excluded package	package	24658-731	24658-731-01	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074673-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1997-02-28
A074673-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1997-02-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074673-001	AB
A074673-002	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 3 · 84 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
2026-08-18 06:07:40	2026-07	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074673-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB	1997-02-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074673-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	1997-02-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074673-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074673-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074673-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074673-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074673-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074673-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074673-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074673-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074673-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074673-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074673-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074673-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074673-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074673-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074673-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074673-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074673-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074673-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074673-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074673-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074673-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074673-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074673-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074673-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074673-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074673-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074673-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074673-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074673-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074673-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074673-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074673-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074673-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074673-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074673-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074673-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074673-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074673-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074673-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074673-002	AB	1	`bb7c543d1eb4…`

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
24658-731-01	Guanfacine	100 in 1 BOTTLE	TABLET	100		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24658-731-01	EA - Each	24658-731	4bf1adaa-8d1e-49db-af3f-8c714a478b8e	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24658-731	GUANFACINE TABLET [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]	4	Legacy NDC, 1 package rows	20190105_ba089e4c-8623-4159-8230-5c7fd02cdb12.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
Guanfacine	GUANFACINE	Major Pharmaceuticals	400be431-ad6c-4783-a513-ca8b47bf43ee	2026-05-04	Adverse reactions	Exact identifier application applno (ANDA): 074673 application number: ANDA074673
Guanfacine	GUANFACINE	PuraCap Laboratories LLC dba Blu Pharmaceuticals	ba089e4c-8623-4159-8230-5c7fd02cdb12	2025-12-11	Adverse reactions	Exact identifier application applno (ANDA): 074673 application number: ANDA074673 ndc (product): 24658-731
Guanfacine	GUANFACINE	Epic Pharma, LLC	fac4a4c2-f5f0-46ef-b76b-315abe9136fa	2023-11-08	Adverse reactions	Exact identifier application applno (ANDA): 074673 application number: ANDA074673
Guanfacine	GUANFACINE	Proficient Rx LP	09442806-db7b-49de-8ffc-e4cb83138349	2020-07-01	Adverse reactions	Exact identifier application applno (ANDA): 074673 application number: ANDA074673

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
197745	guanFACINE HCl 1 MG Oral Tablet	PSN	ba089e4c-8623-4159-8230-5c7fd02cdb12	6
197746	guanFACINE HCl 2 MG Oral Tablet	PSN	ba089e4c-8623-4159-8230-5c7fd02cdb12	6
197745	guanfacine 1 MG Oral Tablet	SCD	ba089e4c-8623-4159-8230-5c7fd02cdb12	6
197746	guanfacine 2 MG Oral Tablet	SCD	ba089e4c-8623-4159-8230-5c7fd02cdb12	6
197745	guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral Tablet	SY	ba089e4c-8623-4159-8230-5c7fd02cdb12	6
197746	guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral Tablet	SY	ba089e4c-8623-4159-8230-5c7fd02cdb12	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24658-731-01	24658073101	100 TABLET in 1 BOTTLE (24658-731-01)	100 tablet	2016-11-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guanfacine Tablets USP, 1 mg and 2 mg Rx Only	PuraCap Laboratories LLC dba Blu Pharmaceuticals \| Epic Pharma, LLC	2025-12-11	HUMAN PRESCRIPTION DRUG LABEL	6