FDA.reportPublic FDA data

NDC 67046-1000-03 - Clonidine 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
67046-1000
Requested NDC
67046-1000-03
Package NDCs from labels
67046-1000-3, 67046-1000-03
Manufacturer
Coupler LLC
Effective date
2026-05-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Clonidine Hydrochloride - Coupler LLCCoupler LLC2026-05-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1000-3Clonidine Hydrochloride30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1000CLONIDINE HYDROCHLORIDE TABLET [COUPLER LLC]1Current NDC, 1 package rows20241116_266af0b1-ce85-6699-e063-6394a90acb4d.zip

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 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.6d7cfb02-e580-4658-a2fe-2149b515d4342026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 884189
unii: W76I6XXF06
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.00c6d67a-bb11-4884-9eeb-4e1b8701a08b2026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.4b889e12-0382-4679-9cec-d6829c59e8532026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA070975
rxcui: 884185
unii: W76I6XXF06
QLONILIKCLONIDINE HYDROCHLORIDECMP Pharma, Inc.826de1dc-378e-4c90-86d1-e33f7a4248cd2026-08-12Warnings, Adverse reactionsExact identifier
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDECoupler LLC58772b44-dec0-7001-e063-6394a90ac40e2026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 884189
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e5d24f52-e0c2-428d-b647-481d63ffd95f2026-08-04Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDERedpharm Drug53df40e7-dd2b-d40e-e063-6394a90a21c42026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEMajor Pharmaceuticals8171776a-dd14-4dcc-8860-3c27d8ea95042026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 884185
rxcui: 884173
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.e96ab74c-eedf-4d71-8a35-d5ec3daa75922026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 884189
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.574640a5-829d-4e9d-be32-832a48cbd8dd2026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.2a183d05-5be7-43e9-a084-700ec05d01e92026-07-02Warnings, Adverse reactionsExact identifier
rxcui: 884185
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDESt. Mary's Medical Park Pharmacy32d72d7b-5881-f431-e063-6394a90a35472026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackcee049ea-a476-433c-971f-2466a6a3263b2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEBryant Ranch Prepackf65d90dc-11b4-4d63-b4a9-30603bc332ea2026-06-24Warnings, Adverse reactionsExact identifier
rxcui: 884189
unii: W76I6XXF06
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.547beb0f-0c12-2ef4-e063-6394a90a6a732026-06-17Warnings, Adverse reactionsExact identifier
application number: ANDA070975
rxcui: 884185
unii: W76I6XXF06
Clonidine hydrochlorideCLONIDINE HYDROCHLORIDEUnit Dose Solutions, Inc.544ea5bf-6713-f034-e063-6394a90a781b2026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
Clonidine HydrochlorideCLONIDINE HYDROCHLORIDEREMEDYREPACK INC.7ec53e25-c50a-48b4-82b0-c0b3626f31dc2026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 884173
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ea1527a5-4939-4ff7-a827-f88a9113a07d2026-05-26Warnings, Adverse reactionsExact identifier
rxcui: 884185
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.be1b921d-152e-4bd5-82bd-56e2f8beef3e2026-05-26Warnings, Adverse reactionsExact identifier
rxcui: 884189
unii: W76I6XXF06
clonidine hydrochlorideCLONIDINE HYDROCHLORIDEASCLEMED USA INC.200afa03-adf3-4dca-8de8-1569701bd0292026-05-20Warnings, Adverse reactionsExact identifier
rxcui: 884185
rxcui: 884173
rxcui: 884189
unii: W76I6XXF06

Reported adverse events (FAERS/openFDA)#

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