FDA.reportPublic FDA data

NDC 70518-4564-00 - Guanfacine

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
70518-4564
Requested NDC
70518-4564-00
Package NDCs from labels
70518-4564-0, 70518-4564-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-02-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Guanfacine Tablets, USP Rx onlyREMEDYREPACK INC.2026-02-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4564-0Guanfacine30 in 1 BLISTER PACKTABLET301

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 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GuanfacineGAUNFACINEA2A Integrated Pharmaceuticals00c3b4d2-fc4d-4e68-9157-eb29d927deaf2025-02-28Adverse reactionsExact identifier
application number: ANDA216828
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINEBryant Ranch Prepack9d558d8e-8b55-41c6-8209-62b1f7bb0dd42025-02-04Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine ERGUANFACINE ERDirect_Rxfae2df3c-2298-a3e1-e053-6294a90aeac42025-01-22Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGUANFACINENORTHSTAR RXLLC0b2afdab-8c92-463e-9734-f2c8b42007772024-12-27Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine ERGUANFACINE ERDirect_rx286214e2-a65b-f43b-e063-6394a90a33be2024-12-03Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GuanfacineGAUNFACINEi3 Pharmaceuticals, LLC387b33dd-829d-4dab-afe4-078fd15590272024-11-05Adverse reactionsExact identifier
application number: ANDA216828
ndc (product): 72319-019
rxcui: 197746
rxcui: 197745
spl id: 262d9624-c761-8f3d-e063-6394a90a2640
spl set id: 387b33dd-829d-4dab-afe4-078fd1559027
unii: PML56A160O
GuanfacineGUANFACINEFosun Pharma USA, Inc261c06ce-8708-d659-e063-6294a90ac3812024-11-04Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINEAmneal Pharmaceuticals LLCd9fdc4b4-5b00-46dd-8700-6e36ceaafb0e2024-10-25Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINE HYDROCHLORIDEAmerican Health Packagingc38bf26f-8a98-4baa-9abb-c83f812900a12024-08-29Adverse reactionsExact identifier
rxcui: 197745
Guanfacine HydrochlorideGUANFACINE HYDROCHLORIDENORTHSTAR RX LLC83d0739b-46fd-6228-e85c-089611067a352024-07-15Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINEA-S Medication Solutions57b8ad03-a5d1-4218-8d3a-40b211da84e62024-04-15Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Guanfacine HydrochlorideGUANFACINE HYDROCHLORIDEXIROMED, LLC4f1e668a-37dd-44f4-ae99-3a1f6dba3eea2024-02-24Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINEEpic Pharma, LLCfac4a4c2-f5f0-46ef-b76b-315abe9136fa2023-11-08Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GuanfacineGUANFACINEActavis Pharma, Inc.a81b956b-f004-4426-ba20-375ccf21eb712023-10-10Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINETWi Pharmaceuticals, Inc.a0c2d95d-805c-4c7d-9733-52073a65218a2023-09-04Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
GUANFACINEGUANFACINEAlembic Pharmaceuticals Limited983b3157-cbea-435d-ba32-9ee7ef95226a2023-08-10Warnings, Adverse reactionsExact identifier
unii: PML56A160O
GUANFACINEGUANFACINE HYDROCHLORIDEAurobindo Pharma Limitede6d4fc3d-4169-44f1-bcb9-1188de40d4e52023-08-08Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745
unii: PML56A160O
Guanfacine extended-releaseGUANFACINEA-S Medication Solutions07797c4a-a799-436b-a77c-a2861a811a992023-05-23Warnings, Adverse reactionsExact identifier
unii: PML56A160O
Guanfacine HydrochlorideGUANFACINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.14146031-8d56-469b-8de8-fe3cf1712e782021-03-30Adverse reactionsExact identifier
rxcui: 197746
rxcui: 197745

Reported adverse events (FAERS/openFDA)#

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