guanfacine

Product NDC
42291-326
11-digit product format
422910326
Labeler code
42291
Product ID
42291-326_435760cc-e7f3-28b9-e063-6294a90a7004
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA200881
Marketing category
ANDA
Marketing start
2015-07-09
Substance
GUANFACINE HYDROCHLORIDE
Active strength
3 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct42291-326IInactivated by FDA2026-08-03
excluded packagepackage42291-32642291-326-01IInactivated by FDA2026-08-03

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200881-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05
A200881-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05
A200881-003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05
A200881-004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200881-001AB
A200881-002AB
A200881-003AB
A200881-004AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200881-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A200881-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A200881-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A200881-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2012-10-05d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200881-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200881-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200881-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200881-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200881-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200881-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200881-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200881-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200881-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200881-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200881-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200881-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200881-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200881-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200881-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200881-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200881-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200881-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200881-004AB1d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
44b80df7-57c9-56d4-c87a-f0d57d327460Product name920260127
4e3af9ef-fc83-b9f5-a7ba-995eabf1f1f0Product name320230308

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-326-01guanfacine100 in 1 BOTTLETABLET, EXTENDED RELEASE1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-326-01EA - Each42291-326d385b975-228d-4754-853f-04c65584455312015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
FUMARIC ACIDINACTIVE INGREDIENT88XHZ13131GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
GLYCERYL BEHENATE/EICOSADIOATEINACTIVE INGREDIENT73CJJ317SRGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE G)INACTIVE INGREDIENTVQ8ZWO78F6GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EGUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GUANFACINE (GUANFACINE) TABLET, EXTENDED RELEASE [AVKARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-326GUANFACINE TABLET, EXTENDED RELEASE [AVKARE]8Current NDC, Legacy NDC, 1 package rows20240110_301f01a7-2b0a-cfba-9c3d-a1dd831785a3.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
guanfacineGUANFACINEActavis Pharma, Inc.3a171942-37af-430d-8b9d-bb678ca2be4b2020-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200881
application number: ANDA200881

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY301f01a7-2b0a-cfba-9c3d-a1dd831785a39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-326-0142291032601100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-326-01) 2015-07-090000-00-00NoNoCurrent