FDA.reportPublic FDA data

cetirizine hydrochloride

Product NDC
71205-207
11-digit product format
712050207
Labeler code
71205
Product ID
71205-207_517ed467-a0d0-43ab-99ce-e6a4808800c4
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078336
Marketing category
ANDA
Marketing start
2007-12-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cetirizine hydrochloride
Listing expiration
2026-12-31

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
71205-207-06cetirizine hydrochloride6 in 1 BOTTLETABLET68
71205-207-10cetirizine hydrochloride10 in 1 BOTTLETABLET108
71205-207-15cetirizine hydrochloride15 in 1 BOTTLETABLET158
71205-207-30cetirizine hydrochloride30 in 1 BOTTLETABLET308
71205-207-60cetirizine hydrochloride60 in 1 BOTTLETABLET608
71205-207-90cetirizine hydrochloride90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-207-06EA - Each71205-20748e3d9bc-69ef-4216-9457-349048e4661412019-11-12
71205-207-10EA - Each71205-2076a23f314-7e7b-4967-ab35-4f4153fd9dcb12019-10-07
71205-207-15EA - Each71205-2077df610f0-7245-4b67-a2bc-cfb155cc687b12019-11-12
71205-207-30EA - Each71205-207b99fdaf2-f2f0-4f23-99bd-d6f1f65c8ded12019-04-11
71205-207-90EA - Each71205-20761bff00e-2867-4f39-959c-753382b8828e12019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-207CETIRIZINE HYDROCHLORIDE TABLET [PROFICIENT RX LP]8Current NDC, Legacy NDC, 6 package rows20220409_198ca875-bb8a-49d5-8809-7121ba119381.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN198ca875-bb8a-49d5-8809-7121ba1193818
1014678cetirizine hydrochloride 10 MG Oral TabletSCD198ca875-bb8a-49d5-8809-7121ba1193818
1014678cetirizine HCl 10 MG Oral TabletSY198ca875-bb8a-49d5-8809-7121ba1193818

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-207-06712050207066 TABLET in 1 BOTTLE (71205-207-06) 6 tablet2019-09-010000-00-00NoNoCurrent
71205-207-107120502071010 TABLET in 1 BOTTLE (71205-207-10) 10 tablet2019-08-010000-00-00NoNoCurrent
71205-207-157120502071515 TABLET in 1 BOTTLE (71205-207-15) 15 tablet2019-10-010000-00-00NoNoCurrent
71205-207-307120502073030 TABLET in 1 BOTTLE (71205-207-30) 30 tablet2019-01-010000-00-00NoNoCurrent
71205-207-607120502076060 TABLET in 1 BOTTLE (71205-207-60) 60 tablet2019-01-010000-00-00NoNoCurrent
71205-207-907120502079090 TABLET in 1 BOTTLE (71205-207-90) 90 tablet2019-01-010000-00-00NoNoCurrent