Guanfacine Hydrochloride

Product NDC
68084-748
11-digit product format
680840748
Labeler code
68084
Product ID
68084-748_d953ffb5-610b-53c8-e053-2a95a90aec67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Guanfacine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA075109
Marketing category
ANDA
Marketing start
2014-05-07
Marketing end
2022-12-31
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
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68084-748DDiscontinued by firm2026-08-11
excluded packagepackage68084-74868084-748-25DDiscontinued by firm2026-08-11

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68084-748-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-748-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-748-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-748-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-748-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-748-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-748-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-748-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-748-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-748-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-748-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-748-25557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075109-001GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25
A075109-002GUANFACINE HYDROCHLORIDEGUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075109-001AB
A075109-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALAB1998-11-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075109-001GUANFACINE HYDROCHLORIDEEQ 1MG BASETABLET / ORALAB1998-11-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A075109-002GUANFACINE HYDROCHLORIDEEQ 2MG BASETABLET / ORALABRS1998-11-25782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075109-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075109-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075109-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075109-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075109-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075109-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075109-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075109-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075109-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075109-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075109-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075109-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075109-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075109-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075109-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075109-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075109-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075109-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075109-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075109-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075109-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075109-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075109-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075109-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075109-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075109-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075109-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075109-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075109-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075109-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075109-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075109-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075109-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075109-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075109-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075109-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075109-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075109-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075109-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A075109-002AB1782e0a99824c…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-748-11EA - Each68084-748403fe7d8-8da2-473b-840c-695093255a8812014-07-02
68084-748-21EA - Each68084-74881bc4ba4-40e7-49d7-966e-348913706d8412014-07-02
68084-748-25EA - Each68084-748a0a80e51-3fa2-493f-ad5f-e75e12f9e33a12016-02-04
68084-748-95EA - Each68084-7481b0cf4b9-34c0-44f5-9083-ef0a2b8694af12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GUANFACINE HYDROCHLORIDEACTIVE INGREDIENTPML56A160OGUANFACINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
GUANFACINEACTIVE MOIETY30OMY4G3MKGUANFACINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGUANFACINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGUANFACINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APGUANFACINE HYDROCHLORIDE TABLET [AMERICAN HEALTH PACKAGING]1

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Guanfacine HydrochlorideGUANFACINEA-S Medication Solutions9f967d68-5aff-4955-8c79-69febf7c38ad2026-05-22Adverse reactionsExact identifier
application applno (ANDA): 075109
application number: ANDA075109
Guanfacine HydrochlorideGUANFACINEAmneal Pharmaceuticals of New York LLC73d50917-c807-4213-8efe-aea2098459362026-04-14Adverse reactionsExact identifier
application applno (ANDA): 075109
application number: ANDA075109
Guanfacine HydrochlorideGUANFACINEAvPAKcc3cc6de-583c-4180-9f4c-9e4c75eb6f382026-02-24Adverse reactionsExact identifier
application applno (ANDA): 075109
application number: ANDA075109
Guanfacine HydrochlorideGUANFACINEPrecision Dose, Inc.a80dfdc4-b9a7-4f8e-af67-dea30bc063ac2025-05-27Adverse reactionsExact identifier
application applno (ANDA): 075109
application number: ANDA075109
Guanfacine HydrochlorideGUANFACINEAmneal Pharmaceuticals LLCd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e2024-10-25Adverse reactionsExact identifier
application applno (ANDA): 075109
application number: ANDA075109

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-748-256808407482530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-748-25) > 1 TABLET in 1 BLISTER PACK (68084-748-95) 30 blister pack2015-12-220000-00-00NoNoCurrent