CETIRIZINE HYDROCHLORIDE

Product NDC
64679-693
11-digit product format
646790693
Labeler code
64679
Product ID
64679-693_bd58a720-81d5-4358-a8d5-a835c600b60d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
SYRUP
Route
ORAL
Labeler
WOCKHARDT LLC.
Application
ANDA078757
Marketing category
ANDA
Marketing start
2009-08-28
Marketing end
0000-00-00
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct64679-693IInactivated by FDA2026-10-05
excluded packagepackage64679-69364679-693-01IInactivated by FDA2026-10-05
excluded packagepackage64679-69364679-693-02IInactivated by FDA2026-10-05
excluded packagepackage64679-69364679-693-03IInactivated by FDA2026-10-05

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 2 · 88 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-693-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-693-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage64679-693-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-693-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-693-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage64679-693-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-693-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-693-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage64679-693-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-693-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-693-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage64679-693-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-693-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-693-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage64679-693-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-693-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-693-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage64679-693-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-693-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-693-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage64679-693-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-693-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-693-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage64679-693-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-693-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-693-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage64679-693-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-693-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-693-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage64679-693-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-693-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-693-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage64679-693-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-693-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-693-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage64679-693-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64679-693-038af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64679-693-028af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage64679-693-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64679-693-03834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64679-693-02834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage64679-693-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64679-693-031332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64679-693-021332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage64679-693-011332a3947898…d4bfe170f9cd…

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

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
A078757-001CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-2884e616aacf4f…
2026-08-18 06:07:402026-07A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-283f01610625f2…
2019-09-15 20:21 UTC2019-09A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2009-08-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078757-001CETIRIZINE HYDROCHLORIDE5MG/5MLSYRUP / ORAL2009-08-28f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64679-693-01CETIRIZINE HYDROCHLORIDE1 in 1 CARTONSYRUP11
64679-693-01CETIRIZINE HYDROCHLORIDE120 mL in 1 BOTTLE, GLASSSYRUP1201
64679-693-02CETIRIZINE HYDROCHLORIDE480 mL in 1 BOTTLE, GLASSSYRUP4801
64679-693-03CETIRIZINE HYDROCHLORIDE480 mL in 1 BOTTLE, PLASTICSYRUP4801

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64679-693CETIRIZINE HYDROCHLORIDE SYRUP [WOCKHARDT LLC.]1Legacy NDC, 4 package rows20100527_cd989627-71ff-479d-a103-c1a22aa9e5e2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNcd989627-71ff-479d-a103-c1a22aa9e5e21
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDcd989627-71ff-479d-a103-c1a22aa9e5e21
1014673cetirizine HCl 1 MG/ML Oral SyrupSYcd989627-71ff-479d-a103-c1a22aa9e5e21
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYcd989627-71ff-479d-a103-c1a22aa9e5e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
64679-693-01646790693011 in 1 CARTONHistorical
64679-693-0264679069302480 mL in 1 BOTTLE, GLASS480 mlHistorical
64679-693-0364679069303480 mL in 1 BOTTLE, PLASTIC480 mlHistorical