FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Product NDC
71205-700
11-digit product format
712050700
Labeler code
71205
Product ID
71205-700_c5844e33-c337-4b62-91ca-de3d388b7d45
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
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 (Allergy)
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
71205-700-00Cetirizine Hydrochloride (Allergy)100 in 1 BOTTLETABLET1004
71205-700-06Cetirizine Hydrochloride (Allergy)6 in 1 BOTTLETABLET64
71205-700-10Cetirizine Hydrochloride (Allergy)10 in 1 BOTTLETABLET104
71205-700-12Cetirizine Hydrochloride (Allergy)12 in 1 BOTTLETABLET124
71205-700-14Cetirizine Hydrochloride (Allergy)14 in 1 BOTTLETABLET144
71205-700-15Cetirizine Hydrochloride (Allergy)15 in 1 BOTTLETABLET154
71205-700-20Cetirizine Hydrochloride (Allergy)20 in 1 BOTTLETABLET204
71205-700-21Cetirizine Hydrochloride (Allergy)21 in 1 BOTTLETABLET214
71205-700-30Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET304
71205-700-60Cetirizine Hydrochloride (Allergy)60 in 1 BOTTLETABLET604
71205-700-72Cetirizine Hydrochloride (Allergy)120 in 1 BOTTLETABLET1204
71205-700-90Cetirizine Hydrochloride (Allergy)90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-700-00EA - Each71205-7008bc643e1-d7d9-4c3f-a429-02fe1bd4a1e912024-06-10
71205-700-10EA - Each71205-700daad57de-d3b2-43e0-8a75-ab0c8a40ac4e12023-02-06
71205-700-20EA - Each71205-7002cbe6b9f-9f3a-4975-bd38-a5f6098b2f1512024-04-05
71205-700-30EA - Each71205-700a2c3acd7-9303-4baa-8650-642aabf8f7ea12023-02-06
71205-700-90EA - Each71205-700be0176c8-01d3-459b-931f-f57979c8b78412023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-700CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [PROFICIENT RX LP]4Current NDC, 12 package rows20240327_d69083c4-b028-453c-8235-560b40ad358b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNd69083c4-b028-453c-8235-560b40ad358b4
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd69083c4-b028-453c-8235-560b40ad358b4
1014678cetirizine HCl 10 MG Oral TabletSYd69083c4-b028-453c-8235-560b40ad358b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71205-700-0071205070000100 TABLET in 1 BOTTLE (71205-700-00) 100 tablet2024-03-08NoNoHistorical
71205-700-06712050700066 TABLET in 1 BOTTLE (71205-700-06) 6 tablet2024-01-29NoNoHistorical
71205-700-107120507001010 TABLET in 1 BOTTLE (71205-700-10) 10 tablet2022-10-20NoNoHistorical
71205-700-127120507001212 TABLET in 1 BOTTLE (71205-700-12) 12 tablet2024-01-29NoNoHistorical
71205-700-147120507001414 TABLET in 1 BOTTLE (71205-700-14) 14 tablet2024-01-29NoNoHistorical
71205-700-157120507001515 TABLET in 1 BOTTLE (71205-700-15) 15 tablet2024-01-29NoNoHistorical
71205-700-207120507002020 TABLET in 1 BOTTLE (71205-700-20) 20 tablet2024-01-29NoNoHistorical
71205-700-217120507002121 TABLET in 1 BOTTLE (71205-700-21) 21 tablet2024-01-29NoNoHistorical
71205-700-307120507003030 TABLET in 1 BOTTLE (71205-700-30) 30 tablet2022-09-16NoNoHistorical
71205-700-607120507006060 TABLET in 1 BOTTLE (71205-700-60) 60 tablet2022-09-16NoNoHistorical
71205-700-7271205070072120 TABLET in 1 BOTTLE (71205-700-72) 120 tablet2024-03-08NoNoHistorical
71205-700-907120507009090 TABLET in 1 BOTTLE (71205-700-90) 90 tablet2022-09-16NoNoHistorical