Cetirizine Hydrochloride

Product NDC
70677-1236
11-digit product format
706771236
Labeler code
70677
Product ID
70677-1236_3996d9c8-9a1e-e9ca-e063-6294a90a4e8c
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
ANDA090182
Marketing category
ANDA
Marketing start
2024-02-02
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
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 HYDROCHLORIDE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii64O047KTOA
Rxcui1014673

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70677-1236-1Cetirizine Hydrochloride1 in 1 CARTONSOLUTION12
70677-1236-1Cetirizine Hydrochloride120 mL in 1 BOTTLESOLUTION1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1236-1ML - Milliliter70677-1236fdd49b78-5ad9-4921-a58d-141bd6bfe5e712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1236CETIRIZINE HYDROCHLORIDE SOLUTION [STRATEGIC SOURCING SERVICES LLC]1Current NDC, 2 package rows20240207_601c2846-30e7-40f1-96b4-64fbed719c0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014673cetirizine HCl 5 MG in 5 mL Oral SolutionPSN601c2846-30e7-40f1-96b4-64fbed719c0b2
1014673cetirizine hydrochloride 1 MG/ML Oral SolutionSCD601c2846-30e7-40f1-96b4-64fbed719c0b2
1014673cetirizine HCl 1 MG/ML Oral SyrupSY601c2846-30e7-40f1-96b4-64fbed719c0b2
1014673cetirizine HCl 5 MG per 5 ML Oral SolutionSY601c2846-30e7-40f1-96b4-64fbed719c0b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70677-1236-1706771236011 BOTTLE in 1 CARTON (70677-1236-1) / 120 mL in 1 BOTTLE1 bottle2024-02-02NoNoHistorical