Allergy Relief

Product NDC
68210-4112
11-digit product format
682104112
Labeler code
68210
Product ID
68210-4112_eecacd64-4f98-6122-e053-2a95a90af7e7
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Spirit Pharmaceutical LLC
Application
ANDA077829
Marketing category
ANDA
Marketing start
2020-09-23
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 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
68210-4112-1Allergy Relief100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4112ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]5Legacy NDC, 1 package rows20250101_9cee1738-ed64-4b4b-9e45-3a340cb68056.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN9cee1738-ed64-4b4b-9e45-3a340cb680565
1014678cetirizine hydrochloride 10 MG Oral TabletSCD9cee1738-ed64-4b4b-9e45-3a340cb680565
1014678cetirizine HCl 10 MG Oral TabletSY9cee1738-ed64-4b4b-9e45-3a340cb680565

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4112-168210411201100 TABLET, FILM COATED in 1 BOTTLE (68210-4112-1) 2020-09-230000-00-00NoNoCurrent