levocetirizine dihydrochloride

Product NDC
43598-669
11-digit product format
435980669
Labeler code
43598
Product ID
43598-669_319344e4-2965-c148-d650-3f8cf580a960
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-03-12
Marketing end
2019-12-31
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct43598-669DDiscontinued by firm2026-08-17
excluded packagepackage43598-66943598-669-22DDiscontinued by firm2026-08-17
excluded packagepackage43598-66943598-669-35DDiscontinued by firm2026-08-17
excluded packagepackage43598-66943598-669-80DDiscontinued by firm2026-08-17

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 · 48 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 packagepackage43598-669-22d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-669-35d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43598-669-80d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-669-22f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-669-35f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43598-669-80f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-669-222ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-669-352ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43598-669-802ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-669-22a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-669-35a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43598-669-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-669-22cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-669-35cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43598-669-80cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-669-22cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-669-35cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43598-669-80cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-669-22302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-669-35302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43598-669-80302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-669-22ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-669-35ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43598-669-80ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-669-220efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-669-350efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43598-669-800efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-669-22ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-669-35ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43598-669-80ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-669-22367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-669-35367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43598-669-80367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-669-22557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-669-35557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43598-669-80557ba5c1ecfa…9c80585c8c6e…

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

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
A210375-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193f01610625f2…
2019-09-15 20:21 UTC2019-09A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A210375-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-01-19e64feba35796…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43598-669-972020-01-31C16284748780-19d75b9d0-edf1-f424-e053-dadaa90a57ce37300043-1b5d-48f2-2656-51b4634c7eb4

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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.1f722b84-08de-7e6a-41ac-2c9d9bb9fb432026-06-04WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEKROGER COMPANYe47658af-e0f3-5765-f568-300ba407dc292026-01-20WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDECVS PHARMACYc8681ca3-27b4-6738-af72-599ff05f2ec82026-01-20WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalgreens Company766b8836-74b8-8af7-b900-b813b4fc175b2026-01-20WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
24HR Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDELEADER/ Cardinal Health 110, Inc.6ba57f12-fd25-c4a6-ff2d-2955116f84c42026-01-20WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAlbertsons Companiese1a6932b-d076-6573-5b88-7b06c3a916812026-01-20WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDESAM'S WEST INCbb8d38b2-117a-fc6b-4ba0-0bc0188cbcd12026-01-19WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDETarget Corporation7e933c85-96b0-b103-e26a-1aa8a1ded58e2026-01-19WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEHEBb13ab6fc-4fec-c870-2c5f-b5e31dec722a2026-01-19WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEDr. Reddy's Laboratories Inc.fb0a3619-9d5b-5c58-82f3-31f031672f332026-01-19WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEWalmart Inc.82da5fa1-3633-2c48-32b9-d15482f308a12026-01-19WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationfafc8149-d59a-1253-ae79-f33a088e37692025-12-10WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEBJWC (Berkley & Jensen / BJ'S)0216f644-767c-ae88-f48f-cd29ac1547ed2025-12-10WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEChain Drug Marketing Association INC61fb8bef-d868-adee-3237-d3268d603ba62025-12-10WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEAMERISOURCEBERGEN DRUG CORPORATIONfdf54de3-16a9-3b28-b4c4-d745322b3d3c2025-12-10WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375
levocetirizine dihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI5036170d-7eeb-65a8-8473-7d98aeb51ee42025-12-10WarningsExact identifier
application applno (ANDA): 210375
application number: ANDA210375