FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiSOD6A38AGA
Rxcui855172

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-501-102024-10-29C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-112024-10-29C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-182024-10-29C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-242024-10-29C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-102024-01-30C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-112024-01-30C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-182024-01-30C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR
76168-501-242024-01-30C16284748780-11030e365-0ebe-111a-e063-dadaa90a10e2Allergy Relief 24HR

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

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 bottle2019-07-02NoNoHistorical