FDA.reportPublic FDA data

Cetirizine HCl

Product NDC
70677-1279
11-digit product format
706771279
Labeler code
70677
Product ID
70677-1279_2e9de837-00b0-491d-a2e3-766fab46380a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine
Dosage form
TABLET
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA078427
Marketing category
ANDA
Marketing start
2025-03-01
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 HCl
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1279-1Cetirizine HCl14 in 1 BOTTLETABLET143
70677-1279-1Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-2Cetirizine HCl30 in 1 BOTTLETABLET303
70677-1279-2Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-3Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-3Cetirizine HCl60 in 1 BOTTLETABLET603
70677-1279-4Cetirizine HCl1 in 1 CARTONTABLET13
70677-1279-4Cetirizine HCl90 in 1 BOTTLETABLET903
70677-1279-5Cetirizine HCl300 in 1 BOTTLETABLET3003
70677-1279-5Cetirizine HCl1 in 1 CARTONTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1279-1EA - Each70677-127963246e3e-43d7-4378-98dd-078c5443cc7d12025-05-14
70677-1279-2EA - Each70677-1279eb504316-ffda-49c2-8db3-b1e1855fe4b612025-05-14
70677-1279-3EA - Each70677-12792e39a72d-e107-4a01-b0ba-1bdc100a49b512025-05-14
70677-1279-4EA - Each70677-1279853f8a6b-588b-4a74-8561-6519d131827312025-05-14
70677-1279-5EA - Each70677-1279674b3c93-67e0-4d42-b057-8eaeefde5ad212025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1279CETIRIZINE HCL (CETIRIZINE) TABLET [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 10 package rows20250406_65b37b00-8efc-4e04-ab97-a03e8af27d33.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN65b37b00-8efc-4e04-ab97-a03e8af27d333
1014678cetirizine hydrochloride 10 MG Oral TabletSCD65b37b00-8efc-4e04-ab97-a03e8af27d333
1014678cetirizine HCl 10 MG Oral TabletSY65b37b00-8efc-4e04-ab97-a03e8af27d333

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1279-1706771279011 BOTTLE in 1 CARTON (70677-1279-1) / 14 TABLET in 1 BOTTLE1 bottle2025-04-03NoNoCurrent
70677-1279-2706771279021 BOTTLE in 1 CARTON (70677-1279-2) / 30 TABLET in 1 BOTTLE1 bottle2025-03-01NoNoCurrent
70677-1279-3706771279031 BOTTLE in 1 CARTON (70677-1279-3) / 60 TABLET in 1 BOTTLE1 bottle2025-03-01NoNoCurrent
70677-1279-4706771279041 BOTTLE in 1 CARTON (70677-1279-4) / 90 TABLET in 1 BOTTLE1 bottle2025-03-01NoNoCurrent
70677-1279-5706771279051 BOTTLE in 1 CARTON (70677-1279-5) / 300 TABLET in 1 BOTTLE1 bottle2025-03-01NoNoCurrent