Guanfacine

Product NDC: 72266-258
Requested package NDC: 72266-258-55
11-digit product format: 722660258
Labeler code: 72266
Product ID: 72266-258_53ff602c-4688-bace-e063-6394a90a2ffd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Fosun Pharma USA, Inc
Application: ANDA217638
Marketing category: ANDA
Marketing start: 2026-04-03
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 4 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 43.

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
A217638-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12
A217638-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12
A217638-003	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12
A217638-004	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217638-001	AB
A217638-002	AB
A217638-003	AB
A217638-004	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 2 · 64 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
2026-09-14 22:38:34	2026-08	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL		2024-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2024-06-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217638-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217638-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217638-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217638-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217638-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217638-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217638-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217638-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217638-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217638-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217638-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217638-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217638-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217638-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217638-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217638-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217638-004	AB	1	`6a471c1ec25d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217638-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217638-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217638-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217638-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217638-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217638-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217638-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217638-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217638-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217638-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217638-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217638-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217638-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217638-004	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUANFACINE HYDROCHLORIDE	4 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
862006	Internal RxNorm lookup
862013	Internal RxNorm lookup
862019	Internal RxNorm lookup
862025	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
261c06ce-8708-d659-e063-6294a90ac381	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
72266-258-55	Guanfacine	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72266-258-55	EA - Each	72266-258	03783841-817a-4aa5-a304-bff1ddc849e9	1	2025-09-12

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
Guanfacine	GUANFACINE	Fosun Pharma USA, Inc	261c06ce-8708-d659-e063-6294a90ac381	2024-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217638 application number: ANDA217638 ndc (package): 72266-258-55 ndc (product): 72266-258 ndc11 (package): 72266025855

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	261c06ce-8708-d659-e063-6294a90ac381	1
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	261c06ce-8708-d659-e063-6294a90ac381	1
862019	guanFACINE 3 MG 24HR Extended Release Oral Tablet	PSN	261c06ce-8708-d659-e063-6294a90ac381	1
862025	guanFACINE 4 MG 24HR Extended Release Oral Tablet	PSN	261c06ce-8708-d659-e063-6294a90ac381	1
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	261c06ce-8708-d659-e063-6294a90ac381	1
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	261c06ce-8708-d659-e063-6294a90ac381	1
862019	24 HR guanfacine 3 MG Extended Release Oral Tablet	SCD	261c06ce-8708-d659-e063-6294a90ac381	1
862025	24 HR guanfacine 4 MG Extended Release Oral Tablet	SCD	261c06ce-8708-d659-e063-6294a90ac381	1
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet	SY	261c06ce-8708-d659-e063-6294a90ac381	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72266-258-55	72266025855	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72266-258-55)	2026-04-03	No	No	Current