FDA.reportPublic FDA data

Cetrizine Hydrochloride

Product NDC
83745-188
11-digit product format
837450188
Labeler code
83745
Product ID
83745-188_6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
APOZEAL PHARMACEUTICALS INC
Application
ANDA090474
Marketing category
ANDA
Marketing start
2025-01-01
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
Cetrizine Hydrochloride
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
83745-188-04Cetrizine Hydrochloride118 mL in 1 BOTTLESOLUTION1185
83745-188-04Cetrizine Hydrochloride1 in 1 CARTONSOLUTION15
83745-188-08Cetrizine Hydrochloride1 in 1 CARTONSOLUTION15
83745-188-08Cetrizine Hydrochloride237 mL in 1 BOTTLESOLUTION2375
83745-188-12Cetrizine Hydrochloride120 mL in 1 BOTTLE, PLASTICSOLUTION1205
83745-188-16Cetrizine Hydrochloride473 mL in 1 BOTTLESOLUTION4735
83745-188-16Cetrizine Hydrochloride1 in 1 CARTONSOLUTION15
83745-188-24Cetrizine Hydrochloride240 mL in 1 BOTTLE, PLASTICSOLUTION2405
83745-188-48Cetrizine Hydrochloride480 mL in 1 BOTTLE, PLASTICSOLUTION4805

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83745-188-04ML - Milliliter83745-188198f4bca-001b-484c-be58-f700eb8ce4ed12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN9c0549cf-4c93-45d9-9eac-3948fa45554e5
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD9c0549cf-4c93-45d9-9eac-3948fa45554e5
1014673cetirizine HCl 1 MG/ML Oral SyrupSY9c0549cf-4c93-45d9-9eac-3948fa45554e5
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY9c0549cf-4c93-45d9-9eac-3948fa45554e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83745-188-04837450188041 BOTTLE in 1 CARTON (83745-188-04) / 118 mL in 1 BOTTLE1 bottle2025-12-22NoNoHistorical
83745-188-08837450188081 BOTTLE in 1 CARTON (83745-188-08) / 237 mL in 1 BOTTLE1 bottle2026-04-16NoNoHistorical
83745-188-1283745018812120 mL in 1 BOTTLE, PLASTIC (83745-188-12) 120 ml2026-04-16NoNoHistorical
83745-188-16837450188161 BOTTLE in 1 CARTON (83745-188-16) / 473 mL in 1 BOTTLE1 bottle2026-04-16NoNoHistorical
83745-188-2483745018824240 mL in 1 BOTTLE, PLASTIC (83745-188-24) 240 ml2026-04-16NoNoHistorical
83745-188-4883745018848480 mL in 1 BOTTLE, PLASTIC (83745-188-48) 480 ml2026-04-16NoNoHistorical