Cetirizine hydrochloride

Product NDC
70692-139
11-digit product format
706920139
Labeler code
70692
Product ID
70692-139_b451c631-6bdc-d42e-e053-2995a90af099
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Strive Pharmaceuticals Inc
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-07-01
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 hydrochloride
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
70692-139-14Cetirizine hydrochloride14 in 1 BOTTLETABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-139CETIRIZINE HYDROCHLORIDE TABLET [STRIVE PHARMACEUTICALS INC]2Current NDC, Legacy NDC, 1 package rows20201118_a4ebeec7-0245-4f77-e053-2995a90a7e7f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNa4ebeec7-0245-4f77-e053-2995a90a7e7f2
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa4ebeec7-0245-4f77-e053-2995a90a7e7f2
1014678cetirizine HCl 10 MG Oral TabletSYa4ebeec7-0245-4f77-e053-2995a90a7e7f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70692-139-147069201391414 TABLET in 1 BOTTLE (70692-139-14) 14 tablet2020-07-010000-00-00NoNoCurrent