Guanfacine extended-release

Product NDC: 70518-4266
Requested package NDC: 70518-4266-0
11-digit product format: 705184266
Labeler code: 70518
Product ID: 70518-4266_400a2b11-b85e-cbb6-e063-6294a90a5242
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205430
Marketing category: ANDA
Marketing start: 2025-01-27
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: 2026-12-31
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A205430-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25
A205430-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25
A205430-003	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25
A205430-004	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205430-001	AB
A205430-002	AB
A205430-003	AB
A205430-004	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205430-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205430-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205430-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205430-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-07-25	`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	A205430-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205430-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205430-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205430-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205430-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205430-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205430-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205430-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205430-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205430-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205430-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205430-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205430-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205430-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205430-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guanfacine extended-release
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
862013	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
8348e63a-5cbc-489e-b7bf-046c65ba2e8e	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
70518-4266-0	Guanfacine extended-release	100 in 1 BOX	TABLET, EXTENDED RELEASE	100		4
70518-4266-1	Guanfacine extended-release	1 in 1 POUCH	TABLET, EXTENDED RELEASE	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4266	GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]	3	Current NDC, 2 package rows	20250529_8348e63a-5cbc-489e-b7bf-046c65ba2e8e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Guanfacine extended-release	GUANFACINE	Apotex Corp.	1c492e87-3406-ddb8-aaf2-e609c2ded503	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	1c5d9514-641a-4c72-a79a-96a0fe5d6fbd	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	07cda4a1-0eb5-491e-8d16-4e6a6feb93ac	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	187bd24b-d69b-4cdf-be4a-c89e9b131b81	2025-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	Bryant Ranch Prepack	178b649f-8c0f-4fea-a168-3ce4ff52129d	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	REMEDYREPACK INC.	8348e63a-5cbc-489e-b7bf-046c65ba2e8e	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430 ndc (package): 70518-4266-0 ndc (product): 70518-4266 ndc11 (package): 70518426600
Guanfacine ER	GUANFACINE ER	Direct_Rx	fae2df3c-2298-a3e1-e053-6294a90aeac4	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430
Guanfacine extended-release	GUANFACINE	A-S Medication Solutions	07797c4a-a799-436b-a77c-a2861a811a99	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205430 application number: ANDA205430

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
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	8348e63a-5cbc-489e-b7bf-046c65ba2e8e	4
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	8348e63a-5cbc-489e-b7bf-046c65ba2e8e	4
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	8348e63a-5cbc-489e-b7bf-046c65ba2e8e	4
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	8348e63a-5cbc-489e-b7bf-046c65ba2e8e	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4266-0	70518426600	100 POUCH in 1 BOX (70518-4266-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-4266-1)	100 pouch	2025-01-27	No	No	Current