Guanfacine

Product NDC
63629-8161
11-digit product format
636298161
Labeler code
63629
Product ID
63629-8161_846438f0-3355-4455-a7e8-f0db48bc6162
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205689
Marketing category
ANDA
Marketing start
2018-08-17
Substance
GUANFACINE HYDROCHLORIDE
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct63629-8161IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-816163629-8161-1IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
A205689-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16
A205689-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16
A205689-003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16
A205689-004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16

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 UTC2026-02A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORAL2017-11-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205689-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2017-11-16d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2025-08-23 18:47 UTC2025-08A205689-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205689-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205689-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205689-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205689-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205689-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205689-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205689-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205689-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205689-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205689-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205689-004AB1301d65b070ca…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GUANFACINE HYDROCHLORIDE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PML56A160OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
862006Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f070a54a-2738-4ef2-a98a-f9e7a7a56f55Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8161-1Guanfacine30 in 1 BOTTLETABLET, EXTENDED RELEASE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8161GUANFACINE TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 1 package rows20250221_f070a54a-2738-4ef2-a98a-f9e7a7a56f55.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGUANFACINEBryant Ranch Prepackc20cc7eb-9de5-407a-8943-c4d2e3f784442026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINEBryant Ranch Prepack6e16cf54-c0d7-47ea-b502-c2146fd87f232026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINEBryant Ranch Prepackba58a5d0-607b-4dca-a63e-92d8dd81d81b2026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINEBryant Ranch Prepackf070a54a-2738-4ef2-a98a-f9e7a7a56f552026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
ndc (product): 63629-8161
GuanfacineGUANFACINESun Pharmaceutical Industries, Inc2d0a0f8e-5098-4ee2-a4ee-d026789923e22026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINEBryant Ranch Prepack9d558d8e-8b55-41c6-8209-62b1f7bb0dd42025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689
GuanfacineGUANFACINENORTHSTAR RXLLC0b2afdab-8c92-463e-9734-f2c8b42007772024-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205689
application number: ANDA205689

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSNf070a54a-2738-4ef2-a98a-f9e7a7a56f555
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCDf070a54a-2738-4ef2-a98a-f9e7a7a56f555
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSYf070a54a-2738-4ef2-a98a-f9e7a7a56f555
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSYf070a54a-2738-4ef2-a98a-f9e7a7a56f555

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8161-16362981610130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-8161-1) 2019-07-020000-00-00NoNoCurrent