FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
53329-652
11-digit product format
533290652
Labeler code
53329
Product ID
53329-652_efd12ec8-8f3d-c1e3-e053-2995a90a685a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Medline Industries, LP
Application
ANDA077498
Marketing category
ANDA
Marketing start
2007-12-27
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-652DDiscontinued by firm2026-08-03
excluded packagepackage53329-65253329-652-38DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077498-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077498-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A077498-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A077498-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A077498-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27a50c72e98297…
2026-08-01 22:54:322026-06A077498-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27a50c72e98297…
2026-08-01 22:54:322026-06A077498-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27a50c72e98297…
2026-08-01 22:54:322026-06A077498-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLC357523b6-618b-4bff-a80d-c62e72a0804e2026-05-08WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.a7da81e1-8865-45c9-83c7-32fb8032ca2e2026-03-19WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMarlex Pharmaceuticals, Inceb917099-fecf-6b55-e053-2995a90aaafa2025-09-23WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.d0d8b376-9001-8776-e053-2a95a90ae6512024-08-12WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC15eaa0d1-d18d-72b1-e063-6394a90a8a942024-04-12WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LPd14feb90-3ca2-4d5b-825c-25fc2252ca382022-06-01WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEOhm Laboratories Inc.161c4122-2c89-46e6-a6ae-db088087330d2021-05-21WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPublix Super Markets Inca0a063a1-e067-480e-afab-7f01165025f42019-08-19WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Consortium, LLC9d7d2342-a594-4851-810b-b7bce1bd07dc2018-08-24WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEValu Merchandisers Company4a8d2887-8ac3-4d54-9e67-4a271d4164262018-08-23WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Quality Choice Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEChain Drug Marketing Association Inc.2e8cc4e3-8386-42de-801f-fef37f6128492018-08-22WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEMarc Glassman, Inc.f30900e6-425f-43e0-81b6-1fa3bd321f0b2018-06-20WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDELIDL US, LLCa210d6b7-0829-4120-bb6d-fee0c2e57b262018-01-09WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEFAMILY DOLLAR SERVICES, INCb326dacc-6123-47a7-9fde-6909db1d780b2018-01-08WarningsExact identifier
application applno (ANDA): 077498
application number: ANDA077498

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-652CETIRIZINE HYDROCHLORIDE TABLET [MEDLINE INDUSTRIES, LP]7Legacy NDC20221217_6823d475-84c6-4d9f-838d-925ccfb96c97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-652-385332906523890 TABLET in 1 BOTTLE (53329-652-38) 90 tablet2007-12-270000-00-00NoNoCurrent