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 1 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGUANFACINEREMEDYREPACK INC.04a3bd2d-9a9c-43e8-a0e2-280e02265f162026-09-04Adverse reactionsExact identifier
rxcui: 197745
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEREMEDYREPACK INC.8348e63a-5cbc-489e-b7bf-046c65ba2e8e2026-09-02Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEREMEDYREPACK INC.ab2e3597-14fc-4614-ae87-0d1d18188a682026-08-03Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEBryant Ranch Prepackc20cc7eb-9de5-407a-8943-c4d2e3f784442026-07-16Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEBryant Ranch Prepack6e16cf54-c0d7-47ea-b502-c2146fd87f232026-07-16Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEBryant Ranch Prepackba58a5d0-607b-4dca-a63e-92d8dd81d81b2026-07-14Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEBryant Ranch Prepackf070a54a-2738-4ef2-a98a-f9e7a7a56f552026-07-14Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINESt. Mary's Medical Park Pharmacy35d3c996-1755-c017-e063-6294a90abc1f2026-06-25Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINESun Pharmaceutical Industries, Inc2d0a0f8e-5098-4ee2-a4ee-d026789923e22026-06-04Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINEA-S Medication Solutions9f967d68-5aff-4955-8c79-69febf7c38ad2026-05-22Adverse reactionsExact identifier
application number: ANDA075109
rxcui: 197745
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEApotex Corp.1c492e87-3406-ddb8-aaf2-e609c2ded5032026-05-06Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINEMajor Pharmaceuticals400be431-ad6c-4783-a513-ca8b47bf43ee2026-05-04Adverse reactionsExact identifier
rxcui: 197745
unii: PML56A160O
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Guanfacine HydrochlorideGUANFACINEAmneal Pharmaceuticals of New York LLC73d50917-c807-4213-8efe-aea2098459362026-04-14Adverse reactionsExact identifier
application number: ANDA075109
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINE HYDROCHLORIDEREMEDYREPACK INC.1b1063ba-fee3-4540-9139-db4b915f82e22026-04-10Adverse reactionsExact identifier
rxcui: 197746
Guanfacine HydrochlorideGUANFACINEAvPAKcc3cc6de-583c-4180-9f4c-9e4c75eb6f382026-02-24Adverse reactionsExact identifier
application number: ANDA075109
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GUANFACINEGUANFACINEGolden State Medical Supply, Inc.4b86e1c1-9cbe-d4a9-e063-6294a90a22742026-02-23Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack1c5d9514-641a-4c72-a79a-96a0fe5d6fbd2026-02-13Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEBryant Ranch Prepack07cda4a1-0eb5-491e-8d16-4e6a6feb93ac2026-02-10Warnings, Adverse reactionsExact identifier
unii: PML56A160O

Reported adverse events (FAERS/openFDA)#

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