FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
61037-479
11-digit product format
610370479
Labeler code
61037
Product ID
61037-479_3b5908fd-b2c0-ba45-e063-6294a90a6fb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
BAJAJ MEDICAL, LLC
Application
ANDA090191
Marketing category
ANDA
Marketing start
2023-09-12
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
61037-479-02CETIRIZINE HYDROCHLORIDE120 mL in 1 BOTTLE, PLASTICSOLUTION1209
61037-479-03CETIRIZINE HYDROCHLORIDE480 mL in 1 BOTTLE, PLASTICSOLUTION4809
61037-479-06CETIRIZINE HYDROCHLORIDE5 mL in 1 CUP, UNIT-DOSESOLUTION59
61037-479-12CETIRIZINE HYDROCHLORIDE5 mL in 1 BOX, UNIT-DOSESOLUTION59
61037-479-04CETIRIZINE HYDROCHLORIDE240 mL in 1 BOTTLE, PLASTICSOLUTION2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61037-479CETIRIZINE HYDROCHLORIDE SOLUTION [BAJAJ MEDICAL, LLC]6Current NDC, 4 package rows20250519_05324e41-ee3f-0e4b-e063-6294a90a102c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN05324e41-ee3f-0e4b-e063-6294a90a102c9
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD05324e41-ee3f-0e4b-e063-6294a90a102c9
1014673cetirizine HCl 1 MG/ML Oral SyrupSY05324e41-ee3f-0e4b-e063-6294a90a102c9
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY05324e41-ee3f-0e4b-e063-6294a90a102c9
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN3b5908f1-faba-c317-e063-6294a90aa8a71
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD3b5908f1-faba-c317-e063-6294a90aa8a71
1014673cetirizine HCl 1 MG/ML Oral SyrupSY3b5908f1-faba-c317-e063-6294a90aa8a71
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY3b5908f1-faba-c317-e063-6294a90aa8a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61037-479-0261037047902120 mL in 1 BOTTLE, PLASTIC (61037-479-02) 120 ml2023-09-12NoNoHistorical
61037-479-0361037047903480 mL in 1 BOTTLE, PLASTIC (61037-479-03) 480 ml2024-07-16NoNoHistorical
61037-479-0461037047904240 mL in 1 BOTTLE, PLASTIC (61037-479-04) 240 ml2025-06-06NoNoHistorical
61037-479-06610370479065 mL in 1 CUP, UNIT-DOSE (61037-479-06) 5 ml2025-06-06NoNoHistorical
61037-479-12610370479125 mL in 1 BOX, UNIT-DOSE (61037-479-12) 5 ml2025-06-06NoNoHistorical