FDA.reportPublic FDA data

Childrens Cetirizine Hydrochloride

Product NDC
0363-4025
11-digit product format
003634025
Labeler code
0363
Product ID
0363-4025_ed5abf26-6de5-46f8-924a-744e4fc5a04e
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA213557
Marketing category
ANDA
Marketing start
2020-09-11
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 mg/1
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
Childrens Cetirizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1011482

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4025-76Childrens Cetirizine Hydrochloride6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING67
0363-4025-76Childrens Cetirizine Hydrochloride4 in 1 CARTONTABLET, ORALLY DISINTEGRATING47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4025-76EA - Each0363-40259913c967-ec56-4193-9891-807673ed2e8212024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4025CHILDRENS CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [WALGREEN CO.]7Current NDC, Legacy NDC, 2 package rows20240420_a9fd9b8f-509b-1ffa-e053-2a95a90a6d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011482cetirizine HCl 10 MG Disintegrating Oral TabletPSNa9fd9b8f-509b-1ffa-e053-2a95a90a6d0f7
1011482cetirizine hydrochloride 10 MG Disintegrating Oral TabletSCDa9fd9b8f-509b-1ffa-e053-2a95a90a6d0f7
1011482cetirizine HCl 10 MG Disintegrating Oral TabletSYa9fd9b8f-509b-1ffa-e053-2a95a90a6d0f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-4025-76003634025764 BLISTER PACK in 1 CARTON (0363-4025-76) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK4 blister pack2020-09-110000-00-00NoNoCurrent