FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
51655-801
11-digit product format
516550801
Labeler code
51655
Product ID
51655-801_4ba8e808-dc3c-03b9-e063-6394a90a61a2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078343
Marketing category
ANDA
Marketing start
2023-01-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-801-522026-01-29C16284748780-149896155-c82e-586f-e063-e6dba90add90Cetirizine Hydrochloride Tablets
51655-801-602026-01-29C16284748780-149896155-c82e-586f-e063-e6dba90add90Cetirizine Hydrochloride Tablets
51655-801-842026-01-29C16284748780-149896155-c82e-586f-e063-e6dba90add90Cetirizine Hydrochloride Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-801-52Cetirizine Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305
51655-801-60Cetirizine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
51655-801-84Cetirizine Hydrochloride14 in 1 BOTTLE, PLASTICTABLET, FILM COATED145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-801CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 3 package rows20230318_f70886af-a8a4-63a0-e053-6294a90a2d2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNf70886af-a8a4-63a0-e053-6294a90a2d2c5
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf70886af-a8a4-63a0-e053-6294a90a2d2c5
1014678cetirizine HCl 10 MG Oral TabletSYf70886af-a8a4-63a0-e053-6294a90a2d2c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-801-525165508015230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-52) 2023-01-25NoNoCurrent
51655-801-6051655080160100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-60) 2023-01-25NoNoCurrent
51655-801-845165508018414 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-801-84) 2023-01-25NoNoCurrent