FDA.reportPublic FDA data

cetirizine hydrochloride

Product NDC
70677-1007
11-digit product format
706771007
Labeler code
70677
Product ID
70677-1007_b13a3e2a-c087-727c-8d9e-90faa85292e6
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
ANDA078343
Marketing category
ANDA
Marketing start
2022-05-12
Marketing end
2027-02-28
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
cetirizine hydrochloride

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
70677-1007-1cetirizine hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
70677-1007-1cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
70677-1007-2cetirizine hydrochloride60 in 1 BOTTLETABLET, FILM COATED603
70677-1007-2cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
70677-1007-3cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13
70677-1007-3cetirizine hydrochloride90 in 1 BOTTLETABLET, FILM COATED903
70677-1007-4cetirizine hydrochloride300 in 1 BOTTLETABLET, FILM COATED3003
70677-1007-4cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1007CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 8 package rows20230422_52b70885-f623-b1c8-29c6-584bff46ed45.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN52b70885-f623-b1c8-29c6-584bff46ed453
1014678cetirizine hydrochloride 10 MG Oral TabletSCD52b70885-f623-b1c8-29c6-584bff46ed453
1014678cetirizine HCl 10 MG Oral TabletSY52b70885-f623-b1c8-29c6-584bff46ed453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-1007-1706771007011 BOTTLE in 1 CARTON (70677-1007-1) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-052026-07-31NoNoHistorical
70677-1007-2706771007021 BOTTLE in 1 CARTON (70677-1007-2) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-052027-02-28NoNoHistorical
70677-1007-3706771007031 BOTTLE in 1 CARTON (70677-1007-3) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-052027-01-31NoNoHistorical
70677-1007-4706771007041 BOTTLE in 1 CARTON (70677-1007-4) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2023-05-052027-02-28NoNoHistorical