FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
0121-0874
11-digit product format
001210874
Labeler code
0121
Product ID
0121-0874_31dc1106-c6ed-4dcd-81e3-206cbd47017b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA078412
Marketing category
ANDA
Marketing start
2024-02-12
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
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 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
0121-0874-04Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1205
0121-0874-16Cetirizine Hydrochloride480 mL in 1 BOTTLESOLUTION4805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0874-04ML - Milliliter0121-0874ee8dd89b-3c9d-4922-8833-172a8a1b5a4412024-07-12
0121-0874-16ML - Milliliter0121-08745349a130-cfae-4e58-9817-4f9d3636630512024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0874CETIRIZINE HYDROCHLORIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]3Current NDC, 2 package rows20240621_71448ab0-e23e-4cf7-940e-7d67e7362fb4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN71448ab0-e23e-4cf7-940e-7d67e7362fb45
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD71448ab0-e23e-4cf7-940e-7d67e7362fb45
1014673cetirizine HCl 1 MG/ML Oral SyrupSY71448ab0-e23e-4cf7-940e-7d67e7362fb45
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY71448ab0-e23e-4cf7-940e-7d67e7362fb45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-0874-0400121087404120 mL in 1 BOTTLE (0121-0874-04) 120 ml2024-06-21NoNoCurrent
0121-0874-1600121087416480 mL in 1 BOTTLE (0121-0874-16) 480 ml2024-02-12NoNoCurrent