levocetirizine dihydrochloride

Product NDC
0536-1144
Requested package NDC
0536-1144-92
11-digit product format
005361144
Labeler code
0536
Product ID
0536-1144_5a7871a8-acf6-8a96-d5b1-d9446a5518cf
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RUGBY LABORATORIES
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-04-20
Marketing end
0000-00-00
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-11440536-1144-92DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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, Related label table
NDCEffectiveRelated label
0536-1144-192025-04-29Drug Facts
0536-1144-922025-04-29Drug Facts
0536-1144-932025-04-29Drug Facts
0536-1144-192025-01-30Drug Facts
0536-1144-922025-01-30Drug Facts
0536-1144-932025-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1144-19EA - Each0536-11443593221e-f1fa-49d0-8756-200169c3e00f12019-05-02
0536-1144-92EA - Each0536-1144b280b33b-7824-4535-8e10-7d2efaaa20dd12018-05-09
0536-1144-93EA - Each0536-114414c13e66-0543-4d46-b9b3-7bf3175b04de12018-05-09

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1144-92005361144921 BOTTLE in 1 CARTON (0536-1144-92) > 35 TABLET, COATED in 1 BOTTLE1 bottle2018-04-200000-00-00NoNoCurrent