FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
71205-709
11-digit product format
712050709
Labeler code
71205
Product ID
71205-709_bb392ca5-d39d-4265-95b2-bc44e133101b
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078343
Marketing category
ANDA
Marketing start
2018-12-17
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-709-00Cetirizine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
71205-709-06Cetirizine Hydrochloride6 in 1 BOTTLETABLET, FILM COATED64
71205-709-10Cetirizine Hydrochloride10 in 1 BOTTLETABLET, FILM COATED104
71205-709-20Cetirizine Hydrochloride20 in 1 BOTTLETABLET, FILM COATED204
71205-709-30Cetirizine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
71205-709-90Cetirizine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-709CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20240727_55b1738c-fa72-4cd1-a8e8-be41b12b593d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN55b1738c-fa72-4cd1-a8e8-be41b12b593d4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD55b1738c-fa72-4cd1-a8e8-be41b12b593d4
1014678cetirizine HCl 10 MG Oral TabletSY55b1738c-fa72-4cd1-a8e8-be41b12b593d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-709-0071205070900100 TABLET, FILM COATED in 1 BOTTLE (71205-709-00) 2025-07-08NoNoCurrent
71205-709-06712050709066 TABLET, FILM COATED in 1 BOTTLE (71205-709-06) 2022-10-310000-00-00NoNoCurrent
71205-709-107120507091010 TABLET, FILM COATED in 1 BOTTLE (71205-709-10) 2022-10-310000-00-00NoNoCurrent
71205-709-147120507091414 TABLET, FILM COATED in 1 BOTTLE (71205-709-14) 2022-10-310000-00-00NoNoCurrent
71205-709-207120507092020 TABLET, FILM COATED in 1 BOTTLE (71205-709-20) 2026-03-040000-00-00NoNoCurrent
71205-709-307120507093030 TABLET, FILM COATED in 1 BOTTLE (71205-709-30) 2022-10-310000-00-00NoNoCurrent
71205-709-607120507096060 TABLET, FILM COATED in 1 BOTTLE (71205-709-60) 2022-10-310000-00-00NoNoCurrent
71205-709-907120507099090 TABLET, FILM COATED in 1 BOTTLE (71205-709-90) 2022-10-310000-00-00NoNoCurrent