FDA.reportPublic FDA data

Cetirizine

Product NDC
50090-5510
11-digit product format
500905510
Labeler code
50090
Product ID
50090-5510_85911f54-1674-47b7-9449-cf2f89fabdb6
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078336
Marketing category
ANDA
Marketing start
2018-06-29
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 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
Cetirizine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5510-12023-02-07C16284748780-1f386c649-b174-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Cetirizine Drug Facts
50090-5510-32023-02-07C16284748780-1f386c649-b174-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Cetirizine Drug Facts
50090-5510-12023-01-30C16284748780-1f386c649-b174-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Cetirizine Drug Facts
50090-5510-32023-01-30C16284748780-1f386c649-b174-0266-e053-dadaa90a7c1aMajor Pharmaceuticals Cetirizine Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5510-1Cetirizine30 in 1 BOTTLETABLET, FILM COATED3011
50090-5510-1Cetirizine1 in 1 CARTONTABLET, FILM COATED111
50090-5510-3Cetirizine90 in 1 BOTTLETABLET, FILM COATED9011
50090-5510-3Cetirizine1 in 1 CARTONTABLET, FILM COATED111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5510-1EA - Each50090-55100f11eed8-bed7-4661-a13f-dc3435dbb74a12022-12-07
50090-5510-3EA - Each50090-551065b12c8c-117a-4861-bf90-808008a1243a12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5510CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 4 package rows20230325_ff782956-03b7-4ae6-b78f-fb7fe78b262d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNff782956-03b7-4ae6-b78f-fb7fe78b262d11
1014678cetirizine hydrochloride 10 MG Oral TabletSCDff782956-03b7-4ae6-b78f-fb7fe78b262d11
1014678cetirizine HCl 10 MG Oral TabletSYff782956-03b7-4ae6-b78f-fb7fe78b262d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5510-1500905510011 BOTTLE in 1 CARTON (50090-5510-1) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent
50090-5510-3500905510031 BOTTLE in 1 CARTON (50090-5510-3) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-04-120000-00-00NoNoCurrent