Cetirizine Hydrochloride

Product NDC
68071-2570
11-digit product format
680712570
Labeler code
68071
Product ID
68071-2570_d0d86f58-9028-077e-e053-2995a90ad40b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078343
Marketing category
ANDA
Marketing start
2018-12-17
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2570IInactivated by FDA2026-08-17
excluded packagepackage68071-257068071-2570-3IInactivated by FDA2026-08-17
excluded packagepackage68071-257068071-2570-7IInactivated by FDA2026-08-17
excluded packagepackage68071-257068071-2570-9IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2570-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2570-7IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2570-9IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2570-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2570-7IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2570-9IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2570-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2570-7IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2570-9IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2570-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2570-7IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2570-9IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2570-3IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2570-7IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2570-9IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2570-3IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2570-7IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2570-9IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2570-9UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2570-7UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2570-3UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2570-9UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2570-7UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2570-3UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2570-9UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2570-7UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2570-3UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2570-3Cetirizine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
68071-2570-7Cetirizine Hydrochloride7 in 1 BOTTLETABLET, FILM COATED73
68071-2570-9Cetirizine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2570CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Legacy NDC, 3 package rows20230718_d0d89544-9f04-561c-e053-2995a90a35bd.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 · 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
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 TabletPSNd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine HCl 10 MG Oral TabletSYd0d89544-9f04-561c-e053-2995a90a35bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2570-36807125700330 TABLET, FILM COATED in 1 BOTTLE (68071-2570-3) 2021-11-150000-00-00NoNoCurrent
68071-2570-7680712570077 TABLET, FILM COATED in 1 BOTTLE (68071-2570-7) 2021-11-150000-00-00NoNoCurrent
68071-2570-96807125700990 TABLET, FILM COATED in 1 BOTTLE (68071-2570-9) 2021-11-150000-00-00NoNoCurrent