FDA.reportPublic FDA data

Cetirizine

Product NDC
0904-7510
11-digit product format
009047510
Labeler code
0904
Product ID
0904-7510_c5217eeb-1332-45da-8a5a-c9bf3d092327
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078336
Marketing category
ANDA
Marketing start
2025-04-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7510-61Cetirizine1 in 1 BLISTER PACKTABLET, FILM COATED13
0904-7510-61Cetirizine100 in 1 CARTONTABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7510-61EA - Each0904-75105ffe6eaf-5493-42bd-a06a-671ed0920e5412025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7510CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]1Current NDC, 2 package rows20250410_71db132d-dca4-47ef-8560-c68ad2258933.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN37c6d1e4-dd88-42a2-a828-539b68aa5dad3
1014678cetirizine HCl 10 MG Oral TabletPSN71db132d-dca4-47ef-8560-c68ad22589333
1014678cetirizine hydrochloride 10 MG Oral TabletSCD37c6d1e4-dd88-42a2-a828-539b68aa5dad3
1014678cetirizine hydrochloride 10 MG Oral TabletSCD71db132d-dca4-47ef-8560-c68ad22589333
1014678cetirizine HCl 10 MG Oral TabletSY37c6d1e4-dd88-42a2-a828-539b68aa5dad3
1014678cetirizine HCl 10 MG Oral TabletSY71db132d-dca4-47ef-8560-c68ad22589333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0904-7510-6100904751061100 BLISTER PACK in 1 CARTON (0904-7510-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2025-04-07NoNoHistorical