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 10 of 13 · 256 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionse626bd59-dd18-465c-b740-9d04eb48c28e2024-03-14Adverse reactionsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride Tablets,10 mgCETIRIZINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d78223ba-80d5-47f8-e053-2a95a90aebdb2024-03-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEProficient Rx LPd69083c4-b028-453c-8235-560b40ad358b2024-03-01WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.6493d4f6-dead-45ec-ade1-28ce624af33d2024-02-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride Sugar Free GrapeCETIRIZINE HYDROCHLORIDEA-S Medication Solutions016b66fd-dde9-4f13-afaf-a8aafbdeed1a2024-01-23WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDESDA Laboratories, Inc.222a7e77-33a6-44ca-9ab1-0bc4fc431aa32024-01-11WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDETWIN MED, LLCd9437d88-da59-5567-e053-2995a90a362b2024-01-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE 10 MGCETIRIZINE HYDROCHLORIDEYYBA CORP0502f197-21e1-44f2-b621-c8df1ccd956e2024-01-03WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
All Day Allergy ReliefCETIRIZINE HYDROCHLORIDEDOLGENCORP, INC.0643ea78-9709-8526-e063-6394a90a227b2023-12-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
CHILDRENS ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsa6492645-8438-4e82-aa31-7e5b4bccb2202023-12-15WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDESpirit Pharmaceutical LLCc9eb5102-5514-4e69-8169-be7341e9fb662023-12-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7deb8ca-4a26-aece-e053-6294a90aa6852023-11-22WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerifoods Trading Companyf6ce3cdf-2e6d-61e8-e053-6294a90af7d32023-11-02WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEHARRIS TEETERb8f68d9d-2d3a-414a-e053-2a95a90a15ec2023-10-30WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Allergy ReliefCETIRIZINE HYDROCHLORIDEWALGREENSf3c66f47-016a-799a-e053-2995a90ad4242023-10-21WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutions84f42ff2-1f51-4cbe-a2bb-dc024d2ff1a42023-09-14WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsf4da9adf-840d-4526-86a6-6666183fd1072023-07-06WarningsName fallback
generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.c0165b0e-d5e9-a028-e053-2a95a90ab4312023-05-25WarningsName 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