GUANFACINE

Product NDC
51407-952
11-digit product format
514070952
Labeler code
51407
Product ID
51407-952_4b86e049-6e94-b8a6-e063-6294a90a1014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
GUANFACINE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA217269
Marketing category
ANDA
Marketing start
2023-08-07
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217269-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07
A217269-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07
A217269-003GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07
A217269-004GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A217269-001AB
A217269-002AB
A217269-003AB
A217269-004AB

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 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217269-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A217269-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A217269-003GUANFACINE HYDROCHLORIDEEQ 3MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A217269-004GUANFACINE HYDROCHLORIDEEQ 4MG BASETABLET, EXTENDED RELEASE / ORALAB2023-08-07d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217269-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217269-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217269-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217269-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217269-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A217269-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217269-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217269-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A217269-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A217269-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A217269-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A217269-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A217269-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A217269-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A217269-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A217269-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217269-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217269-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A217269-004AB1d06236e962d9…

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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
862006Internal RxNorm lookup
862013Internal RxNorm lookup
862019Internal RxNorm lookup
862025Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b86e1c1-9cbe-d4a9-e063-6294a90a2274Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-952-01GUANFACINE100 in 1 BOTTLETABLET, EXTENDED RELEASE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-952-01EA - Each51407-9526d260a93-0976-4278-80c6-aa724ff27af412026-04-20

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
GUANFACINEGUANFACINESt. Mary's Medical Park Pharmacy35d3c996-1755-c017-e063-6294a90abc1f2026-06-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269
GUANFACINEGUANFACINEGolden State Medical Supply, Inc.4b86e1c1-9cbe-d4a9-e063-6294a90a22742026-02-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269
ndc (product): 51407-952
GUANFACINEGUANFACINEA-S Medication Solutions0836a1d5-f1fc-4b94-9667-667278a74c932025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269
GUANFACINEGUANFACINEBryant Ranch Prepack7db29f50-df23-49b1-ad92-05c42fda4ccd2025-06-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269
GUANFACINEGUANFACINEAlembic Pharmaceuticals Inc.9db7def2-c6f9-4d7d-a403-fc615358913a2025-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269
Guanfacine ERGUANFACINE ERDirect_rx286214e2-a65b-f43b-e063-6394a90a33be2024-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269
GUANFACINEGUANFACINEAlembic Pharmaceuticals Limited983b3157-cbea-435d-ba32-9ee7ef95226a2023-08-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217269
application number: ANDA217269

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
862006guanFACINE 1 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862013guanFACINE 2 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanFACINE 3 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862025guanFACINE 4 MG 24HR Extended Release Oral TabletPSN4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86200624 HR guanfacine 1 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86201324 HR guanfacine 2 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86201924 HR guanfacine 3 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
86202524 HR guanfacine 4 MG Extended Release Oral TabletSCD4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862006guanfacine 1 MG (as guanfacine hydrochloride 1.14 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862006guanfacine 1 MG (as guanfacine hydrochloride 1.15 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862013guanfacine 2 MG (as guanfacine hydrochloride 2.28 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862013guanfacine 2 MG (as guanfacine hydrochloride 2.3 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanfacine 3 MG (as guanfacine hydrochloride 3.42 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862019guanfacine 3 MG (as guanfacine hydrochloride 3.45 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862025guanfacine 4 MG (as guanfacine hydrochloride 4.56 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741
862025guanfacine 4 MG (as guanfacine hydrochloride 4.6 MG) 24 HR Extended Release Oral TabletSY4b86e1c1-9cbe-d4a9-e063-6294a90a22741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-952-0151407095201100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51407-952-01) 2026-01-12NoNoCurrent