cetirizine hydrochloride

Product NDC
70677-0142
11-digit product format
706770142
Labeler code
70677
Product ID
70677-0142_dcf6fe2d-509d-b0ff-445f-332de020849d
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA078343
Marketing category
ANDA
Marketing start
2022-05-12
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-0142-1EA - Each70677-0142f31aa2d7-ad38-4841-9793-d24ca909666212022-08-04
70677-0142-2EA - Each70677-0142646a1985-4eda-4d3c-820f-b59ff7cfcb3a12022-11-07
70677-0142-3EA - Each70677-0142f854f515-c18e-4ad8-a692-60b2a46de2a012022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-0142CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]4Legacy NDC20241025_60aec8ce-33e5-a36a-2c61-7c6011c8348a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-0142-1706770142011 BOTTLE in 1 CARTON (70677-0142-1) > 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-05-120000-00-00NoNoCurrent
70677-0142-2706770142021 BOTTLE in 1 CARTON (70677-0142-2) > 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-11-180000-00-00NoNoCurrent
70677-0142-3706770142031 BOTTLE in 1 CARTON (70677-0142-3) > 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-11-180000-00-00NoNoCurrent