FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Product NDC
68788-8204
11-digit product format
687888204
Labeler code
68788
Product ID
68788-8204_ec89e868-59e4-4bbd-8c95-5cf56f7df9ce
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2022-04-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride (Allergy)
Listing expiration
2027-12-31

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
68788-8204-0Cetirizine Hydrochloride (Allergy)100 in 1 BOTTLETABLET1004
68788-8204-1Cetirizine Hydrochloride (Allergy)14 in 1 BOTTLETABLET144
68788-8204-3Cetirizine Hydrochloride (Allergy)30 in 1 BOTTLETABLET304
68788-8204-5Cetirizine Hydrochloride (Allergy)15 in 1 BOTTLETABLET154
68788-8204-6Cetirizine Hydrochloride (Allergy)60 in 1 BOTTLETABLET604
68788-8204-9Cetirizine Hydrochloride (Allergy)90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8204-0EA - Each68788-820450eeece5-1af1-4965-b4f4-6c26673e0ed512023-06-06
68788-8204-1EA - Each68788-8204533cd032-fec4-4ca4-be12-f67c225e9d5112023-06-06
68788-8204-3EA - Each68788-82045fdad5bc-978c-48c4-878d-17d6441577f212023-06-06
68788-8204-5EA - Each68788-8204bbe538f2-665d-4adf-bc0c-918569c4f11b12023-06-06
68788-8204-6EA - Each68788-8204d9760758-83c3-4059-a2d8-f83db7896c4412023-06-06
68788-8204-9EA - Each68788-8204fdbe6f78-5b39-45ad-98b1-e9e6256b380d12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8204CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) TABLET [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 6 package rows20240912_73122009-531b-4929-bf57-494a6fc65b73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN73122009-531b-4929-bf57-494a6fc65b734
1014678cetirizine hydrochloride 10 MG Oral TabletSCD73122009-531b-4929-bf57-494a6fc65b734
1014678cetirizine HCl 10 MG Oral TabletSY73122009-531b-4929-bf57-494a6fc65b734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8204-068788820400100 TABLET in 1 BOTTLE (68788-8204-0) 100 tablet2022-04-01NoNoCurrent
68788-8204-16878882040114 TABLET in 1 BOTTLE (68788-8204-1) 14 tablet2022-04-01NoNoCurrent
68788-8204-36878882040330 TABLET in 1 BOTTLE (68788-8204-3) 30 tablet2022-04-01NoNoCurrent
68788-8204-56878882040515 TABLET in 1 BOTTLE (68788-8204-5) 15 tablet2022-04-01NoNoCurrent
68788-8204-66878882040660 TABLET in 1 BOTTLE (68788-8204-6) 60 tablet2022-04-01NoNoCurrent
68788-8204-96878882040990 TABLET in 1 BOTTLE (68788-8204-9) 90 tablet2022-04-01NoNoCurrent