FDA.reportPublic FDA data

levocetirizine dihydrochloride

Product NDC
63868-473
11-digit product format
638680473
Labeler code
63868
Product ID
63868-473_62bd5a02-2f4d-697f-856c-7516352417c1
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Chain Drug Marketing Association INC
Application
ANDA210375
Marketing category
ANDA
Marketing start
2020-06-24
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 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 · 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…

Additional Listing Data#

Finished product
Yes
Brand name base
levocetirizine dihydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOD6A38AGAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
61fb8bef-d868-adee-3237-d3268d603ba6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-473-35levocetirizine dihydrochloride35 in 1 BOTTLETABLET, COATED353
63868-473-35levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-473-35EA - Each63868-473a6073c9c-05bc-48c4-b483-789737d804f412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-473LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION INC]2Current NDC, Legacy NDC, 2 package rows20231014_61fb8bef-d868-adee-3237-d3268d603ba6.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 · 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
ndc (product): 63868-473
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN61fb8bef-d868-adee-3237-d3268d603ba63
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD61fb8bef-d868-adee-3237-d3268d603ba63
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY61fb8bef-d868-adee-3237-d3268d603ba63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-473-35638680473351 BOTTLE in 1 CARTON (63868-473-35) / 35 TABLET, COATED in 1 BOTTLE1 bottle2020-06-240000-00-00NoNoCurrent