FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
83939-0004
11-digit product format
839390004
Labeler code
83939
Product ID
83939-0004_42780c27-b003-a427-e063-6394a90ace93
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
VERITYRX, LLC
Application
ANDA078343
Marketing category
ANDA
Marketing start
2018-12-17
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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078343-001CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15
A078343-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15d8e5a09893c0…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

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
1014678Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
42778a1c-6894-8646-e063-6294a90a6cb5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83939-0004-1Cetirizine Hydrochloride1 in 1 POUCHTABLET, FILM COATED11
83939-0004-2Cetirizine Hydrochloride1 in 1 POUCHTABLET, FILM COATED11
83939-0004-2Cetirizine Hydrochloride50 in 1 BOX, UNIT-DOSETABLET, FILM COATED501
83939-0004-3Cetirizine Hydrochloride1 in 1 POUCHTABLET, FILM COATED11
83939-0004-3Cetirizine Hydrochloride100 in 1 BOX, UNIT-DOSETABLET, FILM COATED1001

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSPreferred Pharmaceuticals Inc.14a885e5-5e75-4a18-b5bc-6aaa748712db2026-03-25WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSProficient Rx LP55b1738c-fa72-4cd1-a8e8-be41b12b593d2026-03-01WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSSportpharm LLCd5297bdb-823c-4318-a797-5311d5cf0df82026-02-06WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSNorthwind Health Company, LLCf70886af-a8a4-63a0-e053-6294a90a2d2c2026-01-01WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSVERITYRX, LLC42778a1c-6894-8646-e063-6294a90a6cb52025-10-31WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
ndc (product): 83939-0004
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSBryant Ranch Prepacke4324124-13f8-4450-9fd6-686bd6e255782025-10-28WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.206ab55a-3720-6205-d710-6e79535714182025-07-17WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSStrategic Sourcing Services LLC52b70885-f623-b1c8-29c6-584bff46ed452025-07-17WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDiscount Drug Mart, Incc7c7e496-3682-c764-88ef-d2a09823f71e2025-07-16WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.e4eca4df-9ad8-b7c4-b512-bfaed56737892025-07-16WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDr.Reddy's Laboratories Limitedde152651-bfcd-856a-8329-a2ac93a376bc2011-09-30WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN42778a1c-6894-8646-e063-6294a90a6cb51
1014678cetirizine hydrochloride 10 MG Oral TabletSCD42778a1c-6894-8646-e063-6294a90a6cb51
1014678cetirizine HCl 10 MG Oral TabletSY42778a1c-6894-8646-e063-6294a90a6cb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83939-0004-1839390004011 TABLET, FILM COATED in 1 POUCH (83939-0004-1) 2025-11-10NoNoCurrent
83939-0004-28393900040250 POUCH in 1 BOX, UNIT-DOSE (83939-0004-2) / 1 TABLET, FILM COATED in 1 POUCH50 pouch2025-11-03NoNoCurrent
83939-0004-383939000403100 POUCH in 1 BOX, UNIT-DOSE (83939-0004-3) / 1 TABLET, FILM COATED in 1 POUCH100 pouch2025-11-03NoNoCurrent