FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
43598-811
11-digit product format
435980811
Labeler code
43598
Product ID
43598-811_adfee3f6-660a-305c-2cf4-bd509acfad36
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Tablets
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc.
Application
ANDA078343
Marketing category
ANDA
Marketing start
2018-12-17
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
Cetirizine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014678

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-811-05Cetirizine Hydrochloride1 in 1 CARTONTABLET, FILM COATED16
43598-811-05Cetirizine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
43598-811-12Cetirizine Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1006
43598-811-13Cetirizine Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3006
43598-811-15Cetirizine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
43598-811-30Cetirizine Hydrochloride1 in 1 CARTONTABLET, FILM COATED16
43598-811-30Cetirizine Hydrochloride300 in 1 BOTTLETABLET, FILM COATED3006
43598-811-90Cetirizine Hydrochloride1 in 1 CARTONTABLET, FILM COATED16
43598-811-90Cetirizine Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-811-12EA - Each43598-8119da26ba6-b106-4f2c-bd31-bdc87a7141f612021-04-08
43598-811-15EA - Each43598-811b8010875-5e4d-48ba-a035-b1a7cf2faaf412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-811CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE TABLETS) TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.]5Current NDC, Legacy NDC, 9 package rows20230628_e4eca4df-9ad8-b7c4-b512-bfaed5673789.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNe4324124-13f8-4450-9fd6-686bd6e25578102
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe4324124-13f8-4450-9fd6-686bd6e25578102
1014678cetirizine HCl 10 MG Oral TabletSYe4324124-13f8-4450-9fd6-686bd6e25578102
1014678cetirizine HCl 10 MG Oral TabletPSNe4eca4df-9ad8-b7c4-b512-bfaed56737896
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe4eca4df-9ad8-b7c4-b512-bfaed56737896
1014678cetirizine HCl 10 MG Oral TabletSYe4eca4df-9ad8-b7c4-b512-bfaed56737896
1014678cetirizine HCl 10 MG Oral TabletPSNf70886af-a8a4-63a0-e053-6294a90a2d2c5
1014678cetirizine hydrochloride 10 MG Oral TabletSCDf70886af-a8a4-63a0-e053-6294a90a2d2c5
1014678cetirizine HCl 10 MG Oral TabletSYf70886af-a8a4-63a0-e053-6294a90a2d2c5
1014678cetirizine HCl 10 MG Oral TabletPSN14a885e5-5e75-4a18-b5bc-6aaa748712db4
1014678cetirizine HCl 10 MG Oral TabletPSN55b1738c-fa72-4cd1-a8e8-be41b12b593d4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD14a885e5-5e75-4a18-b5bc-6aaa748712db4
1014678cetirizine hydrochloride 10 MG Oral TabletSCD55b1738c-fa72-4cd1-a8e8-be41b12b593d4
1014678cetirizine HCl 10 MG Oral TabletSY55b1738c-fa72-4cd1-a8e8-be41b12b593d4
1014678cetirizine HCl 10 MG Oral TabletSY14a885e5-5e75-4a18-b5bc-6aaa748712db4
1014678cetirizine HCl 10 MG Oral TabletPSNd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine HCl 10 MG Oral TabletSYd0d89544-9f04-561c-e053-2995a90a35bd3
1014678cetirizine HCl 10 MG Oral TabletPSNd5297bdb-823c-4318-a797-5311d5cf0df82
1014678cetirizine HCl 10 MG Oral TabletPSN206ab55a-3720-6205-d710-6e79535714182
1014678cetirizine hydrochloride 10 MG Oral TabletSCDd5297bdb-823c-4318-a797-5311d5cf0df82
1014678cetirizine hydrochloride 10 MG Oral TabletSCD206ab55a-3720-6205-d710-6e79535714182
1014678cetirizine HCl 10 MG Oral TabletSYd5297bdb-823c-4318-a797-5311d5cf0df82
1014678cetirizine HCl 10 MG Oral TabletSY206ab55a-3720-6205-d710-6e79535714182
1014678cetirizine HCl 10 MG Oral TabletPSN42778a1c-6894-8646-e063-6294a90a6cb51
1014678cetirizine hydrochloride 10 MG Oral TabletSCD42778a1c-6894-8646-e063-6294a90a6cb51
1014678cetirizine HCl 10 MG Oral TabletSY42778a1c-6894-8646-e063-6294a90a6cb51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-811-05435980811051 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-170000-00-00NoNoCurrent
43598-811-1243598081112100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12) 2019-09-030000-00-00NoNoCurrent
43598-811-1343598081113300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13) 2019-09-030000-00-00NoNoCurrent
43598-811-1543598081115500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15) 2019-09-030000-00-00NoNoCurrent
43598-811-30435980811301 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-170000-00-00NoNoCurrent
43598-811-90435980811901 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-12-170000-00-00NoNoCurrent