FDA.reportPublic FDA data

levocetirizine dihydrochloride

Product NDC
0363-5529
11-digit product format
003635529
Labeler code
0363
Product ID
0363-5529_7d5d0782-387a-6951-f77d-da28a0065fef
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Walgreens Company
Application
ANDA210375
Marketing category
ANDA
Marketing start
2018-03-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
levocetirizine dihydrochloride
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-5529-10levocetirizine dihydrochloride5 in 1 BLISTER PACKTABLET, COATED510
0363-5529-10levocetirizine dihydrochloride2 in 1 CARTONTABLET, COATED210
0363-5529-12levocetirizine dihydrochloride120 in 1 BOTTLETABLET, COATED12010
0363-5529-12levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED110
0363-5529-35levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED110
0363-5529-35levocetirizine dihydrochloride35 in 1 BOTTLETABLET, COATED3510
0363-5529-55levocetirizine dihydrochloride55 in 1 BOTTLETABLET, COATED5510
0363-5529-55levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED110
0363-5529-80levocetirizine dihydrochloride80 in 1 BOTTLETABLET, COATED8010
0363-5529-80levocetirizine dihydrochloride1 in 1 CARTONTABLET, COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-5529-35EA - Each0363-55298e8445f6-8fb8-48b7-8dd6-da2a0bc33ab012022-06-06
0363-5529-55EA - Each0363-55297197572d-ad91-4f6b-9ce9-8221f7a32ce312022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-5529LEVOCETIRIZINE DIHYDROCHLORIDE TABLET, COATED [WALGREENS COMPANY]7Current NDC, Legacy NDC, 10 package rows20231014_766b8836-74b8-8af7-b900-b813b4fc175b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN766b8836-74b8-8af7-b900-b813b4fc175b10
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD766b8836-74b8-8af7-b900-b813b4fc175b10
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY766b8836-74b8-8af7-b900-b813b4fc175b10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-5529-10003635529102 BLISTER PACK in 1 CARTON (0363-5529-10) / 5 TABLET, COATED in 1 BLISTER PACK2 blister pack2018-04-170000-00-00NoNoCurrent
0363-5529-12003635529121 BOTTLE in 1 CARTON (0363-5529-12) / 120 TABLET, COATED in 1 BOTTLE1 bottle2021-01-150000-00-00NoNoCurrent
0363-5529-35003635529351 BOTTLE in 1 CARTON (0363-5529-35) / 35 TABLET, COATED in 1 BOTTLE1 bottle2018-03-260000-00-00NoNoCurrent
0363-5529-55003635529551 BOTTLE in 1 CARTON (0363-5529-55) / 55 TABLET, COATED in 1 BOTTLE1 bottle2018-03-260000-00-00NoNoCurrent
0363-5529-80003635529801 BOTTLE in 1 CARTON (0363-5529-80) / 80 TABLET, COATED in 1 BOTTLE1 bottle2018-03-260000-00-00NoNoCurrent