FDA.reportPublic FDA data

NDC 67046-680-03 - Cetirizine

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
67046-680
Requested NDC
67046-680-03
Package NDCs from labels
67046-680-30, 67046-680-03
Manufacturer
Contract Pharmacy Services-PA | Coupler Enterprises Inc.
Effective date
2018-04-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cetirizine - Contract Pharmacy Services-PA | Coupler Enterprises Inc.Contract Pharmacy Services-PA | Coupler Enterprises Inc.2018-04-22HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-680-302022-01-28C16284748780-1d6a99b39-b742-a426-e053-dadaa90af4c2Cetirizine 10mg 680 "These highlights do not include all the information needed to use" "see full prescribing information for" "Initial U.S. Approval"

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-680-30Cetirizine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-680CETIRIZINE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20180422_6a707324-b32b-9741-e053-2a91aa0a2af2.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 2 of 25 · 488 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
allergy reliefCETIRIZINE HYDROCHLORIDEWalgreen Company678dcc09-55da-4d9d-a39a-c450c61c387b2026-08-18WarningsExact identifier
application number: ANDA078336
rxcui: 1014678
unii: 64O047KTOA
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c8202658-422f-41db-bdee-7bb95b972b322026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 312593
unii: X0Z7454B90
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.e5bd5728-ea7c-4f16-832b-8d58fe14b9942026-08-17Warnings, Adverse reactionsExact identifier
unii: X0Z7454B90
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.c4449fa8-a637-4780-8e19-51cb54e1ee682026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA210971
unii: X0Z7454B90
AMAZON BASICS ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC52163488-0b56-529d-e063-6294a90afc622026-08-17WarningsExact identifier
unii: 64O047KTOA
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.95aa9ffb-66bb-4049-a241-0e1166b4c2642026-08-14Warnings, Adverse reactionsExact identifier
rxcui: 312593
unii: X0Z7454B90
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.8606d9b8-4529-4689-8c93-7114c84c2e542026-08-14Warnings, Adverse reactionsExact identifier
unii: X0Z7454B90
allergy relief childrensCETIRIZINE HCLCVS Pharmacy1a20acb5-207f-4499-a4c3-8733454555382026-08-13WarningsExact identifier
unii: 64O047KTOA
Childrens Allergy ReliefCETIRIZINE HCLCVS Pharmacy0210f9e5-c35b-4cfa-92d1-48555e99f1f32026-08-13WarningsExact identifier
unii: 64O047KTOA
CHILDRENS ALL DAY ALLERGYCETIRIZINE HCLAmazon.com Services LLC29bac87e-8559-47be-838d-c00e57f9f7ba2026-08-12WarningsExact identifier
unii: 64O047KTOA
Cetirizine HClCETIRIZINEGLENMARK THERAPEUTICS INC., USA04b08c52-5390-4cdb-a9e7-fca81fffdc732026-08-07WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US LLCbcbbcb24-2a58-917a-e053-2a95a90af9a92026-08-07WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Prazosin HydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.2f86fc8e-71c1-4749-b67e-86d86cf1d9842026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 312593
unii: X0Z7454B90
equate allergy reliefCETIRIZINE HYDROCHLORIDEWal-Mart Stores Incb33eb97f-5ac3-4eb7-b23a-cf550ce462872026-08-05WarningsExact identifier
application number: ANDA078336
rxcui: 1014678
unii: 64O047KTOA
prazosin hydrochloridePRAZOSIN HYDROCHLORIDECoupler LLC583b4b06-71e4-4696-e063-6294a90a15bf2026-08-04Warnings, Adverse reactionsExact identifier
unii: X0Z7454B90
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252026-08-03WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2026-08-03WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEUnichem Pharmaceuticals (USA), Inc.af18ca44-615e-48ef-b678-7a9ae02e0f2a2026-08-03WarningsExact identifier
unii: 64O047KTOA
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECardinal Health 107, LLC0b0190c7-acfd-4140-bcaf-9fe835ebaf492026-07-30WarningsExact identifier
rxcui: 1014678
unii: 64O047KTOA
prazosin hydrochloridePRAZOSIN HYDROCHLORIDEREMEDYREPACK INC.a1f5ec80-a9bc-43b0-b3f9-4caaea861cb42026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 312593
unii: X0Z7454B90

Reported adverse events (FAERS/openFDA)#

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