Allergy Relief 24HR

Product NDC
76168-501
11-digit product format
761680501
Labeler code
76168
Product ID
76168-501_259de08e-0294-07bb-e063-6294a90a66cb
Type
HUMAN OTC DRUG
Nonproprietary name
Levocetirizine dihydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
VELOCITY PHARMA LLC
Application
ANDA211551
Marketing category
ANDA
Marketing start
2019-07-02
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

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 · 25 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76168-501-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76168-501-24367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76168-501-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76168-501-18367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76168-501-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76168-501-24557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76168-501-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76168-501-18557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76168-501-118af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76168-501-248af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76168-501-108af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76168-501-188af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76168-501-11834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76168-501-24834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76168-501-10834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76168-501-18834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76168-501-111332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76168-501-241332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76168-501-101332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76168-501-181332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A211551-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203f01610625f2…
2019-09-15 20:21 UTC2019-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211551-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2018-11-20cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief 24HR
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
8ba208dc-34fe-453a-8658-ed4f232e1a94Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-501-10Allergy Relief 24HR1 in 1 CARTONTABLET16
76168-501-10Allergy Relief 24HR10 in 1 BOTTLETABLET106
76168-501-11Allergy Relief 24HR1 in 1 CARTONTABLET16
76168-501-11Allergy Relief 24HR100 in 1 BOTTLETABLET1006
76168-501-18Allergy Relief 24HR180 in 1 BOTTLETABLET1806
76168-501-18Allergy Relief 24HR1 in 1 CARTONTABLET16
76168-501-24Allergy Relief 24HR240 in 1 BOTTLETABLET2406
76168-501-24Allergy Relief 24HR1 in 1 CARTONTABLET16
76168-501-36Allergy Relief 24HR360 in 1 BOTTLETABLET3606
76168-501-36Allergy Relief 24HR1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-501ALLERGY RELIEF 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [VELOCITY PHARMA LLC]6Current NDC, Legacy NDC, 10 package rows20241031_8ba208dc-34fe-453a-8658-ed4f232e1a94.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Levocetirizine DihydrochlorideLEVOCETIRIZINE DIHYDROCHLORIDEMicro Labs Limited78ff8e86-ee5b-4626-aa81-49e974febf1d2025-02-16WarningsExact identifier
application applno (ANDA): 211551
application number: ANDA211551
Allergy Relief 24HRLEVOCETIRIZINE DIHYDROCHLORIDEVELOCITY PHARMA LLC8ba208dc-34fe-453a-8658-ed4f232e1a942024-10-29WarningsExact identifier
application applno (ANDA): 211551
application number: ANDA211551
ndc (product): 76168-501

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN8ba208dc-34fe-453a-8658-ed4f232e1a946
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD8ba208dc-34fe-453a-8658-ed4f232e1a946
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY8ba208dc-34fe-453a-8658-ed4f232e1a946

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76168-501-10761680501101 BOTTLE in 1 CARTON (76168-501-10) / 10 TABLET in 1 BOTTLE1 bottle2019-07-020000-00-00NoNoCurrent
76168-501-11761680501111 BOTTLE in 1 CARTON (76168-501-11) / 100 TABLET in 1 BOTTLE1 bottle2019-12-130000-00-00NoNoCurrent
76168-501-18761680501181 BOTTLE in 1 CARTON (76168-501-18) / 180 TABLET in 1 BOTTLE1 bottle2019-12-130000-00-00NoNoCurrent
76168-501-24761680501241 BOTTLE in 1 CARTON (76168-501-24) / 240 TABLET in 1 BOTTLE1 bottle2019-12-130000-00-00NoNoCurrent
76168-501-36761680501361 BOTTLE in 1 CARTON (76168-501-36) / 360 TABLET in 1 BOTTLE1 bottle2019-07-02NoNoCurrent