Cetirizine Hydrochloride

Product NDC
45802-626
11-digit product format
458020626
Labeler code
45802
Product ID
45802-626_2263eac3-aa51-4b35-8535-db7e21cf5660
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA078398
Marketing category
ANDA
Marketing start
2008-07-24
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078398-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078398-001AA

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-1787673890dc5c…
2021-03-12 10:30 UTC2021-03A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-173f01610625f2…
2019-09-15 20:21 UTC2019-09A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARS2008-06-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-173f0d92c62455…
2023-05-13 08:27 UTC2023-05A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17053a50430f4f…
2023-01-26 05:58 UTC2023-01A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078398-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORALAARS2008-06-17cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A078398-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078398-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078398-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078398-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078398-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078398-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078398-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078398-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078398-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078398-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078398-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078398-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078398-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078398-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078398-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078398-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078398-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078398-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078398-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078398-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078398-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A078398-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078398-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078398-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078398-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A078398-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A078398-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078398-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078398-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078398-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078398-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078398-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078398-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078398-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A078398-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A078398-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078398-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078398-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078398-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078398-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014673Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2f47dbc5-dfb4-425c-9fe4-777fa3c4e72eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-626-26Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1209
45802-626-26Cetirizine Hydrochloride1 in 1 CARTONSOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-626-26ML - Milliliter45802-62665749fab-769d-4d55-88b5-08901c521dd812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine hydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
cetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
WATERINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SYRUP [PERRIGO NEW YORK INC]3
Cetirizine hydrochlorideACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
cetirizineACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2
WATERINACTIVE INGREDIENT059QF0KO0RCETIRIZINE HYDROCHLORIDE SYRUP [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-626CETIRIZINE HYDROCHLORIDE SOLUTION [PADAGIS ISRAEL PHARMACEUTICALS LTD]8Current NDC, Legacy NDC, 2 package rows20230808_2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e.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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e874264a-becc-45d0-b934-779eab5f50852026-03-25Adverse reactionsExact identifier
application applno (ANDA): 078398
application number: ANDA078398
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e2025-05-29Adverse reactionsExact identifier
application applno (ANDA): 078398
application number: ANDA078398
ndc (product): 45802-626

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine HCl 1 MG/ML Oral SyrupSY2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY2f47dbc5-dfb4-425c-9fe4-777fa3c4e72e9
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 1 MG/ML Oral SyrupSYe874264a-becc-45d0-b934-779eab5f50854
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa28ff91a-34d7-4aac-ad3a-fa82e9ffeb464
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYe874264a-becc-45d0-b934-779eab5f50854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-626-26458020626261 BOTTLE in 1 CARTON (45802-626-26) / 120 mL in 1 BOTTLE1 bottle2008-07-240000-00-00NoNoCurrent