Guanfacine

Product NDC: 24979-533
11-digit product format: 249790533
Labeler code: 24979
Product ID: 24979-533_6634768f-1e5a-4604-9587-fe5ffbd7e331
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Guanfacine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Upsher-Smith Laboratories, LLC
Application: ANDA201408
Marketing category: ANDA
Marketing start: 2017-07-07
Substance: GUANFACINE
Active strength: 1 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
A201408-001	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02
A201408-002	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02
A201408-003	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02
A201408-004	GUANFACINE HYDROCHLORIDE	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201408-001	AB
A201408-002	AB
A201408-003	AB
A201408-004	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	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201408-001	GUANFACINE HYDROCHLORIDE	EQ 1MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201408-002	GUANFACINE HYDROCHLORIDE	EQ 2MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201408-003	GUANFACINE HYDROCHLORIDE	EQ 3MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201408-004	GUANFACINE HYDROCHLORIDE	EQ 4MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2015-06-02	`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	A201408-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201408-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201408-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201408-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201408-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201408-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201408-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201408-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201408-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201408-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201408-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201408-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201408-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201408-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201408-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201408-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201408-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201408-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A201408-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Guanfacine
Brand name suffix: Extended-Release
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GUANFACINE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
30OMY4G3MK	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
07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	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	SPL version
24979-533-00	Guanfacine Extended-Release	100000 in 1 DRUM	TABLET, EXTENDED RELEASE	100000	15
24979-533-01	Guanfacine Extended-Release	100 in 1 BOTTLE	TABLET, EXTENDED RELEASE	100	15
24979-533-10	Guanfacine Extended-Release	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24979-533-01	EA - Each	24979-533	af3aed04-8f1e-48bb-8b9a-bc7e6c87a27d	1	2017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24979-533	GUANFACINE EXTENDED-RELEASE (GUANFACINE) TABLET, EXTENDED RELEASE [UPSHER-SMITH LABORATORIES, LLC]	15	Current NDC, Legacy NDC, 3 package rows	20250430_07a701e2-39b7-4bb1-a7c7-d9baed4ab18a.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 Extended-Release	GUANFACINE	REMEDYREPACK INC.	3ec4fed6-cafc-49a0-9540-8d70ac435769	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201408 application number: ANDA201408
Guanfacine Extended-Release	GUANFACINE	Golden State Medical Supply, Inc.	6006df06-0448-462d-b81e-7add50a6d71b	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201408 application number: ANDA201408
Guanfacine Extended-Release	GUANFACINE	REMEDYREPACK INC.	36fd53a6-7006-4955-a3cd-b1c08cf84d6c	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201408 application number: ANDA201408
Guanfacine Extended-Release	GUANFACINE	Upsher-Smith Laboratories, LLC	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201408 application number: ANDA201408 ndc (product): 24979-533
Guanfacine Extended-Release	GUANFACINE	Proficient Rx LP	6460ad33-4feb-4a4d-9958-501084046389	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201408 application number: ANDA201408

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862019	guanFACINE 3 MG 24HR Extended Release Oral Tablet	PSN	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862025	guanFACINE 4 MG 24HR Extended Release Oral Tablet	PSN	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862019	24 HR guanfacine 3 MG Extended Release Oral Tablet	SCD	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862025	24 HR guanfacine 4 MG Extended Release Oral Tablet	SCD	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet	SY	07a701e2-39b7-4bb1-a7c7-d9baed4ab18a	15
862006	guanFACINE 1 MG 24HR Extended Release Oral Tablet	PSN	36fd53a6-7006-4955-a3cd-b1c08cf84d6c	13
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	36fd53a6-7006-4955-a3cd-b1c08cf84d6c	13
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	36fd53a6-7006-4955-a3cd-b1c08cf84d6c	13
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	36fd53a6-7006-4955-a3cd-b1c08cf84d6c	13
862006	guanFACINE 1 MG 24HR Extended Release Oral Tablet	PSN	6006df06-0448-462d-b81e-7add50a6d71b	12
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	6006df06-0448-462d-b81e-7add50a6d71b	12
862019	guanFACINE 3 MG 24HR Extended Release Oral Tablet	PSN	6006df06-0448-462d-b81e-7add50a6d71b	12
862025	guanFACINE 4 MG 24HR Extended Release Oral Tablet	PSN	6006df06-0448-462d-b81e-7add50a6d71b	12
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	6006df06-0448-462d-b81e-7add50a6d71b	12
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	6006df06-0448-462d-b81e-7add50a6d71b	12
862019	24 HR guanfacine 3 MG Extended Release Oral Tablet	SCD	6006df06-0448-462d-b81e-7add50a6d71b	12
862025	24 HR guanfacine 4 MG Extended Release Oral Tablet	SCD	6006df06-0448-462d-b81e-7add50a6d71b	12
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet	SY	6006df06-0448-462d-b81e-7add50a6d71b	12
862006	guanFACINE 1 MG 24HR Extended Release Oral Tablet	PSN	6460ad33-4feb-4a4d-9958-501084046389	2
862013	guanFACINE 2 MG 24HR Extended Release Oral Tablet	PSN	6460ad33-4feb-4a4d-9958-501084046389	2
862019	guanFACINE 3 MG 24HR Extended Release Oral Tablet	PSN	6460ad33-4feb-4a4d-9958-501084046389	2
862025	guanFACINE 4 MG 24HR Extended Release Oral Tablet	PSN	6460ad33-4feb-4a4d-9958-501084046389	2
862006	24 HR guanfacine 1 MG Extended Release Oral Tablet	SCD	6460ad33-4feb-4a4d-9958-501084046389	2
862013	24 HR guanfacine 2 MG Extended Release Oral Tablet	SCD	6460ad33-4feb-4a4d-9958-501084046389	2
862019	24 HR guanfacine 3 MG Extended Release Oral Tablet	SCD	6460ad33-4feb-4a4d-9958-501084046389	2
862025	24 HR guanfacine 4 MG Extended Release Oral Tablet	SCD	6460ad33-4feb-4a4d-9958-501084046389	2
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862006	guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862013	guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862019	guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2
862025	guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral Tablet	SY	6460ad33-4feb-4a4d-9958-501084046389	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24979-533-00	24979053300	100000 TABLET, EXTENDED RELEASE in 1 DRUM (24979-533-00)	2024-07-01		No	No	Current
24979-533-01	24979053301	100 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-533-01)	2017-07-07	0000-00-00	No	No	Current
24979-533-10	24979053310	1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (24979-533-10)	2017-07-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guanfacine Extended-Release	Golden State Medical Supply, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	12
Guanfacine Extended-Release	REMEDYREPACK INC.	2026-02-11	HUMAN PRESCRIPTION DRUG LABEL	13
Guanfacine Extended-Release	Upsher-Smith Laboratories, LLC \| TWi Pharmaceuticals, Inc. \| Bora Pharmaceutical Laboratories Inc. Zhongli Plant \| Apace KY, LLC. \| Bora Pharmaceutical Laboratories Inc.	2025-04-29	HUMAN PRESCRIPTION DRUG LABEL	15
Guanfacine Extended-Release	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2