FDA.reportPublic FDA data

Cetirizine Hydrochloride Oral Solution

Product NDC
83745-185
11-digit product format
837450185
Labeler code
83745
Product ID
83745-185_b350aaa9-197e-4ebc-8315-6ea307dcdb2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride Oral Solution
Dosage form
SOLUTION
Route
ORAL
Labeler
APOZEAL PHARMACEUTICALS INC
Application
ANDA078870
Marketing category
ANDA
Marketing start
2024-12-20
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
1 mg/mL
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 Oral Solution
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83745-185-04Cetirizine Hydrochloride Oral Solution120 mL in 1 BOTTLESOLUTION1202
83745-185-08Cetirizine Hydrochloride Oral Solution240 mL in 1 BOTTLESOLUTION2402
83745-185-16Cetirizine Hydrochloride Oral Solution480 mL in 1 BOTTLESOLUTION4802

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83745-185-04ML - Milliliter83745-1852187b40a-0691-4375-a1fb-37b61be2accb12025-02-10
83745-185-08ML - Milliliter83745-185a663c855-9076-4882-9177-b595a3d9756912025-02-10
83745-185-16ML - Milliliter83745-1854bfa04ae-a413-43a1-adbf-916e9063547312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83745-185CETIRIZINE HYDROCHLORIDE ORAL SOLUTION SOLUTION [APOZEAL PHARMACEUTICALS INC]1Current NDC, 3 package rows20241222_9c6a440b-bd0f-414b-bab3-3b2f57c479d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9c6a440b-bd0f-414b-bab3-3b2f57c479d72
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9c6a440b-bd0f-414b-bab3-3b2f57c479d72
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9c6a440b-bd0f-414b-bab3-3b2f57c479d72
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9c6a440b-bd0f-414b-bab3-3b2f57c479d72
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNa03d33dc-a84c-4ab7-88a8-77333bfcb8e71
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDa03d33dc-a84c-4ab7-88a8-77333bfcb8e71
1014673cetirizine HCl 1 MG/ML Oral SyrupSYa03d33dc-a84c-4ab7-88a8-77333bfcb8e71
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYa03d33dc-a84c-4ab7-88a8-77333bfcb8e71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83745-185-0483745018504120 mL in 1 BOTTLE (83745-185-04) 120 ml2024-12-20NoNoHistorical
83745-185-0883745018508240 mL in 1 BOTTLE (83745-185-08) 240 ml2024-12-20NoNoHistorical
83745-185-1683745018516480 mL in 1 BOTTLE (83745-185-16) 480 ml2024-12-20NoNoHistorical