FDA.reportPublic FDA data

NDC 68084-748-95 - Guanfacine Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
68084-748
Requested NDC
68084-748-95
Package NDCs from labels
68084-748-95, 68084-748-25
Manufacturer
American Health Packaging
Effective date
2022-03-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guanfacine Hydrochloride - American Health PackagingAmerican Health Packaging2022-03-03HUMAN PRESCRIPTION DRUG LABEL

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 2 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGAUNFACINEREMEDYREPACK INC.46dcdeaa-ec2a-48d6-b315-fcc3dd71c5e02026-02-03Adverse reactionsExact identifier
rxcui: 197746
unii: PML56A160O
GuanfacineGUANFACINECoupler LLC4973deb3-57ec-1ef3-e063-6294a90aa0352026-01-28Adverse reactionsExact identifier
rxcui: 197746
unii: PML56A160O
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
GuanfacineGUANFACINEREMEDYREPACK INC.145a191d-9049-4014-9c42-503fdde063dc2026-01-14Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINECoupler LLC266c6819-cd71-55d0-e063-6394a90ab1572026-01-08Adverse reactionsExact identifier
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINEAdvagen Pharma Ltd87e1ad56-a7b9-431d-a5d2-d52fb64735c72025-12-31Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
GuanfacineGUANFACINEPuraCap Laboratories LLC dba Blu Pharmaceuticalsba089e4c-8623-4159-8230-5c7fd02cdb122025-12-11Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GUANFACINE HYDROCHLORIDEGUANFACINEChartwell RX, LLCfa7ae501-ee34-4e50-9052-7952e36bbd0e2025-12-10Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINESlate Run Pharmaceuticals, LLCed65ca51-b9b0-43b9-9826-03a7be256a2a2025-12-01Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack187bd24b-d69b-4cdf-be4a-c89e9b131b812025-11-05Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEAjanta Pharma USA Inc.830c0be8-2137-46ee-94c6-aa048b7de35f2025-11-05Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack178b649f-8c0f-4fea-a168-3ce4ff52129d2025-10-30Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEA-S Medication Solutions0836a1d5-f1fc-4b94-9667-667278a74c932025-08-28Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEUnichem Pharmaceuticals (USA), Inc.f4e3c976-8811-4388-92b3-d248d705f8b12025-07-22Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEBryant Ranch Prepack7db29f50-df23-49b1-ad92-05c42fda4ccd2025-06-27Warnings, Adverse reactionsExact identifier
unii: PML56A160O
IntunivGUANFACINETakeda Pharmaceuticals America, Inc.b972af81-3a37-40be-9fe1-3ddf598525282025-06-23Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINEPrecision Dose, Inc.a80dfdc4-b9a7-4f8e-af67-dea30bc063ac2025-05-27Adverse reactionsExact identifier
application number: ANDA075109
rxcui: 197745
unii: PML56A160O
GUANFACINEGUANFACINEAlembic Pharmaceuticals Inc.9db7def2-c6f9-4d7d-a403-fc615358913a2025-05-21Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINEAdvagen Pharma Limitede16beec7-9acd-4cd1-be5c-b666ad7d24302025-04-24Warnings, Adverse reactionsExact identifier
unii: PML56A160O

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.