FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
16571-134
11-digit product format
165710134
Labeler code
16571
Product ID
16571-134_8ed398ca-3d43-43b4-9597-4457d6943357
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090191
Marketing category
ANDA
Marketing start
2024-07-16
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
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
16571-134-12CETIRIZINE HYDROCHLORIDE120 mL in 1 BOTTLE, PLASTICSOLUTION1203
16571-134-48CETIRIZINE HYDROCHLORIDE480 mL in 1 BOTTLE, PLASTICSOLUTION4803

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-134-12ML - Milliliter16571-134bf92dffc-89d6-41ac-af73-f3258bf3ff6812024-08-12
16571-134-48ML - Milliliter16571-13447ed3fbe-a39b-4f54-8e9c-b1c521dfe10512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-134CETIRIZINE HYDROCHLORIDE SOLUTION [RISING PHARMA HOLDINGS, INC.]2Current NDC, 2 package rows20240718_efabbad5-a162-45c8-a896-5af58e5d2d39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSNefabbad5-a162-45c8-a896-5af58e5d2d393
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCDefabbad5-a162-45c8-a896-5af58e5d2d393
1014673cetirizine HCl 1 MG/ML Oral SyrupSYefabbad5-a162-45c8-a896-5af58e5d2d393
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSYefabbad5-a162-45c8-a896-5af58e5d2d393

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-134-1216571013412120 mL in 1 BOTTLE, PLASTIC (16571-134-12) 120 ml2024-07-16NoNoCurrent
16571-134-4816571013448480 mL in 1 BOTTLE, PLASTIC (16571-134-48) 480 ml2024-07-16NoNoCurrent