Over-the-counter drug · ANDA

Cetirizine (cetirizine hydrochloride) NDC 55154-0194

Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)55154-0194Labeler and product segments. Claims need a package NDC.
Product NDC at billing width55154-0194Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
55154-0194-05515401940010 BLISTER PACK in 1 BAG (55154-0194-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Nov 7, 2025

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Cetirizine
Generic name (nonproprietary)
cetirizine hydrochloride
Active ingredients
Cetirizine hydrochloride — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Product type
Over-the-counter drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 078336
Marketing start
Listing expires
Other FDA classes
Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 55154-0194_597b2e28-63a6-41b6-9914-b4eb9965ffabSPL ID 597b2e28-63a6-41b6-9914-b4eb9965ffabSPL set ID 37c6d1e4-dd88-42a2-a828-539b68aa5dadRxCUI 1014678UNII 64O047KTOA
Pharmacologic class
Histamine-1 Receptor Antagonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455154019400 followed by a unit qualifier and the quantity

Package 55154-0194-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078336

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078336
ProductStrengthForm · routeLabelerProduct NDC
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7065
TopCare All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralTopco Associates LLC36800-458
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPadagis Israel Pharmaceuticals Ltd45802-919
good neighbor pharmacy all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmerisource Bergen24385-998
All Day Allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralHyVee Inc42507-458
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7064
dg health all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralDolgencorp Inc55910-458
betr remedies all day allergy reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralLive Betr LLC80267-409
Medline Industriescetirizine hclCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralMedline Industries, LP53329-036
kirkland signature aller tec allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCostco Wholesale Company63981-458
Up and Up Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralTarget Corporation11673-502
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralPD-Rx Pharmaceuticals, Inc.72789-343
CareOne Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAmerican Sales Company41520-781
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-123
Allergy Relief Indoor and Outdoor Allergiescetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralCVS Pharmacy59779-458
Goodnow Allergy Reliefcetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralGobrands, Inc82501-0422
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralVERITYRX, LLC83939-0003
Good Sense all day allergycetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc68788-4023
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-5510
cetirizine hydrochlorideCetirizine hydrochloride 10 mg/1TabletOralAphena Pharma Solutions - Tennessee, LLC71610-862

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