Allergy Relief

Product NDC
68210-4136
11-digit product format
682104136
Labeler code
68210
Product ID
68210-4136_ee8ba190-2c2f-7ca2-e053-2a95a90a01a0
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
2021-04-28
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68210-4136-12025-01-30C16284748780-12cef2736-8531-d83d-e063-dadaa90ab31fAllergy Relief (Cetirizine HCl Tablets)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4136-1Allergy Relief1 in 1 CARTONTABLET, FILM COATED15
68210-4136-1Allergy Relief14 in 1 BLISTER PACKTABLET, FILM COATED145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4136ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [SPIRIT PHARMACEUTICAL LLC]5Legacy NDC, 2 package rows20231208_c10a4e14-da8c-41d1-e053-2a95a90a9023.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNc10a4e14-da8c-41d1-e053-2a95a90a90235
1014678cetirizine hydrochloride 10 MG Oral TabletSCDc10a4e14-da8c-41d1-e053-2a95a90a90235
1014678cetirizine HCl 10 MG Oral TabletSYc10a4e14-da8c-41d1-e053-2a95a90a90235

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68210-4136-1682104136011 BLISTER PACK in 1 CARTON (68210-4136-1) > 14 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2021-04-280000-00-00NoNoCurrent