Guanfacine Hydrochloride

Product NDC: 42291-310
11-digit product format: 422910310
Labeler code: 42291
Product ID: 42291-310_d57aa7ec-71d1-5d86-e053-2995a90ad25d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Guanfacine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA075109
Marketing category: ANDA
Marketing start: 2021-07-02
Marketing end: 0000-00-00
Substance: GUANFACINE HYDROCHLORIDE
Active strength: 1 mg/1
Pharmacologic classes: Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42291-310		D	Discontinued by firm	2026-08-11
excluded product	product	42291-310		I	Inactivated by FDA	2026-08-11
excluded package	package	42291-310	42291-310-90	D	Discontinued by firm	2026-08-11
excluded package	package	42291-310	42291-310-01	I	Inactivated by FDA	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 60 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-310-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42291-310-90	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-310-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42291-310-90	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-310-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42291-310-90	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-310-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42291-310-90	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-310-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42291-310-90	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-310-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42291-310-90	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-310-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42291-310-90	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-310-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42291-310-90	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-310-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42291-310-90	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-310-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42291-310-90	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-310-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42291-310-90	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-310-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42291-310-90	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42291-310-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42291-310-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42291-310-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42291-310-90	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	42291-310-90	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	42291-310-90	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42291-310-01	2024-01-30	C162847	48780-1	1030e365-3572-111a-e063-dadaa90a10e2	Guanfacine Tablets, USP 1mg
42291-310-90	2022-09-06	C162847	48780-1	d6a99b39-bc36-a426-e053-dadaa90af4c2	Guanfacine Tablets, USP Rx Only
42291-310-90	2022-01-28	C162847	48780-1	d6a99b39-bc36-a426-e053-dadaa90af4c2	Guanfacine Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42291-310-01	Guanfacine Hydrochloride	100 in 1 BOTTLE	TABLET	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-310-01	EA - Each	42291-310	63e2d1c0-f92a-49e7-845e-967e3133c314	1	2021-08-05
42291-310-90	EA - Each	42291-310	1aaba89a-fc4a-4580-b536-63c7ec494e25	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
GUANFACINE HYDROCHLORIDE	ACTIVE INGREDIENT	PML56A160O	GUANFACINE HYDROCHLORIDE TABLET [AVKARE, INC.]	6
GUANFACINE	ACTIVE MOIETY	30OMY4G3MK	GUANFACINE HYDROCHLORIDE TABLET [AVKARE, INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	GUANFACINE HYDROCHLORIDE TABLET [AVKARE, INC.]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	GUANFACINE HYDROCHLORIDE TABLET [AVKARE, INC.]	6
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	GUANFACINE HYDROCHLORIDE TABLET [AVKARE, INC.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-310	GUANFACINE HYDROCHLORIDE TABLET [AVKARE]	2	Legacy NDC, 1 package rows	20220114_c624aaeb-890b-78ec-e053-2a95a90aafef.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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197745	guanFACINE HCl 1 MG Oral Tablet	PSN	c624aaeb-890b-78ec-e053-2a95a90aafef	2
197745	guanfacine 1 MG Oral Tablet	SCD	c624aaeb-890b-78ec-e053-2a95a90aafef	2
197745	guanfacine 1 MG (as guanfacine HCl 1.15 MG) Oral Tablet	SY	c624aaeb-890b-78ec-e053-2a95a90aafef	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-310-01	42291031001	100 TABLET in 1 BOTTLE (42291-310-01)	100 tablet	2021-07-02	0000-00-00	No	No	Current
42291-310-90	42291031090	90 TABLET in 1 BOTTLE (42291-310-90)	90 tablet	2011-03-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guanfacine Tablets, USP 1mg	AvKARE	2022-01-13	HUMAN PRESCRIPTION DRUG LABEL	2
Guanfacine Tablets, USP Rx Only	AvKARE, Inc.	2020-04-02	HUMAN PRESCRIPTION DRUG LABEL	13