FDA.reportPublic FDA data

Application 078680

Type
ANDA
Sponsor
UNICHEM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078680-001CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-06-26
A078680-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-06-26
A078680-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-06-26
A078680-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-06-26

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.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-2684e616aacf4f…
2026-09-14 22:38:342026-08A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-2684e616aacf4f…
2026-09-14 22:38:342026-08A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-2684e616aacf4f…
2026-09-14 22:38:342026-08A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-2684e616aacf4f…
2026-08-18 06:07:402026-07A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-26caaa826d4ba7…
2026-08-18 06:07:402026-07A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078680-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078680-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2009-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078680-003CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-06-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078680-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-06-265bbf6a4d5a75…

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 12 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCc3e987c5-7ca1-4514-aa0a-6668ff2937c52022-01-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.f0a3e654-5fec-4f98-84da-4c30500633b42021-10-28WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company833e8904-d37d-4478-af7c-8287f2d079a72021-08-16WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.95bf367c-eea8-73f9-e053-2a95a90a3dea2021-07-12WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp, LLCba7d3995-c992-457c-a628-f036d77cc6382021-06-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
rexall all day allergy reliefCETIRIZINE HYDROCHLORIDEDolgencorp, LLC4d79fb74-1895-4efe-8016-c0dd5ed10f7a2021-06-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEOhm Laboratories Inc.161c4122-2c89-46e6-a6ae-db088087330d2021-05-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEKROGER COMPANYb8b2af96-af48-5f63-e053-2995a90a7d7c2021-05-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCc111f6f3-e190-447f-b4a4-e277af6414832021-05-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCd9ebebb5-736a-4019-8c1a-030148de9d022021-05-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCaf8ff570-8f72-4343-b7e1-e977221f5b012021-04-09WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC0b6e8c63-a76c-4184-a9cc-9691378c3ee52021-03-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEFred's, Inc.55e799b2-e325-4286-aa9a-b88e99ab11462020-12-13WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEC.D.M.A., Inc.b4feed95-86ca-411c-99b5-773e485e752f2020-12-13WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inca4ebeec7-0245-4f77-e053-2995a90a7e7f2020-11-17WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLCf0f486e1-2eeb-4eaa-b557-908bcbf973a82020-09-14WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEDISCOUNT DRUG MART844e0e60-f293-4588-9f34-c866bdad6f532020-09-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
All Day AllergyCETIRIZINE HYDROCHLORIDEAmerisource Bergen6ce39876-47bf-4147-885d-4eb0aeb66fd02020-06-18WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
top care all day allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC1a217b8a-621a-4b6d-a7ed-37b04f829d662020-06-08WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Ince64db82c-6632-421e-8212-e0879445c4d62020-06-04WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
29300-133cetirizine hydrochloridecetirizine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-134cetirizine hydrochloridecetirizine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-330cetirizine hydrochloridecetirizine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent
29300-340cetirizine hydrochloridecetirizine hydrochlorideUnichem Pharmaceuticals (USA), Inc.ANDACurrent