FDA.reportPublic FDA data

NDC 68094-065-59 - 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
68094-065
Requested NDC
68094-065-59
Package NDCs from labels
68094-065-59, 68094-065-62
Manufacturer
Precision Dose, Inc.
Effective date
2025-05-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guanfacine Tablets, USP 1 mgPrecision Dose, Inc.2025-05-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-065-59Guanfacine Hydrochloride10 in 1 BLISTER PACKTABLET102
68094-065-62Guanfacine Hydrochloride3 in 1 CARTONTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-065GUANFACINE HYDROCHLORIDE (GUANFACINE) TABLET [PRECISION DOSE, INC.]1Current NDC, 2 package rows20230131_a80dfdc4-b9a7-4f8e-af67-dea30bc063ac.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-065-59EA - Each68094-0655f870357-588e-46b1-9548-718e84b3860b12023-04-07
68094-065-62EA - Each68094-065c9cf849f-adca-4a55-9ee4-7caff5fb626312023-04-07

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 · 64 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
ndc (product): 53746-711
rxcui: 197746
rxcui: 197745
spl id: 98111f92-dc41-4939-b554-65b3f97a3e19
spl set id: 73d50917-c807-4213-8efe-aea209845936
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.