Guanfacine Hydrochloride

Product NDC: 53746-713
11-digit product format: 537460713
Labeler code: 53746
Product ID: 53746-713_98111f92-dc41-4939-b554-65b3f97a3e19
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Guanfacine
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA075109
Marketing category: ANDA
Marketing start: 2022-04-15
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 2 mg/1
Pharmacologic classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A075109-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25
A075109-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075109-001	AB
A075109-002	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 · 82 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	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB		1998-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075109-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL	AB		1998-11-25	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075109-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET / ORAL	AB	RS	1998-11-25	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A075109-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075109-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075109-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075109-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075109-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075109-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075109-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075109-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075109-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075109-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075109-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075109-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075109-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075109-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075109-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075109-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075109-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075109-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075109-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075109-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075109-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075109-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075109-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075109-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075109-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075109-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075109-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075109-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A075109-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guanfacine Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUANFACINE HYDROCHLORIDE	2 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197745	Internal RxNorm lookup
197746	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
73d50917-c807-4213-8efe-aea209845936	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
53746-713-01	Guanfacine Hydrochloride	100 in 1 BOTTLE	TABLET	100		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-713-01	EA - Each	53746-713	aed42d53-cec8-42bf-9479-7ae1055c559b	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-713	GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	2	Current NDC, Legacy NDC, 1 package rows	20230217_73d50917-c807-4213-8efe-aea209845936.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guanfacine Hydrochloride	GUANFACINE	A-S Medication Solutions	9f967d68-5aff-4955-8c79-69febf7c38ad	2026-05-22	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109
Guanfacine Hydrochloride	GUANFACINE	Amneal Pharmaceuticals of New York LLC	73d50917-c807-4213-8efe-aea209845936	2026-04-14	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109 ndc (product): 53746-713
Guanfacine Hydrochloride	GUANFACINE	AvPAK	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	2026-02-24	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109
Guanfacine Hydrochloride	GUANFACINE	Precision Dose, Inc.	a80dfdc4-b9a7-4f8e-af67-dea30bc063ac	2025-05-27	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109
Guanfacine Hydrochloride	GUANFACINE	Amneal Pharmaceuticals LLC	d9fdc4b4-5b00-46dd-8700-6e36ceaafb0e	2024-10-25	Adverse reactions	Exact identifier application applno (ANDA): 075109 application number: ANDA075109

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	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	10
197746	guanFACINE HCl 2 MG Oral Tablet	PSN	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	10
197745	guanfacine 1 MG Oral Tablet	SCD	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	10
197746	guanfacine 2 MG Oral Tablet	SCD	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	10
197745	guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral Tablet	SY	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	10
197746	guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral Tablet	SY	cc3cc6de-583c-4180-9f4c-9e4c75eb6f38	10
197745	guanFACINE HCl 1 MG Oral Tablet	PSN	73d50917-c807-4213-8efe-aea209845936	3
197746	guanFACINE HCl 2 MG Oral Tablet	PSN	73d50917-c807-4213-8efe-aea209845936	3
197745	guanfacine 1 MG Oral Tablet	SCD	73d50917-c807-4213-8efe-aea209845936	3
197746	guanfacine 2 MG Oral Tablet	SCD	73d50917-c807-4213-8efe-aea209845936	3
197745	guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral Tablet	SY	73d50917-c807-4213-8efe-aea209845936	3
197746	guanfacine 2 MG (as guanfacine HCl 2.3 MG) Oral Tablet	SY	73d50917-c807-4213-8efe-aea209845936	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-713-01	53746071301	100 TABLET in 1 BOTTLE (53746-713-01)	100 tablet	2022-04-15	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	Amneal Pharmaceuticals of New York LLC	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	3
Guanfacine Tablets, USP	AvPAK	2026-02-24	HUMAN PRESCRIPTION DRUG LABEL	10