Over-the-counter drug · ANDA

Medline Industries (cetirizine hcl) NDC 53329-036

Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Medline Industries, LP

NDC codes

FDA NDC Directory
Product NDC (as listed)53329-036Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53329-0036Add 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
53329-036-05533290036051 BOTTLE in 1 CARTON (53329-036-05) / 30 TABLET, FILM COATED in 1 BOTTLE (53329-036-33)Marketed from Aug 28, 2026
53329-036-09533290036091 BOTTLE in 1 CARTON (53329-036-09) / 90 TABLET, FILM COATED in 1 BOTTLE (53329-036-38)Marketed from Aug 28, 2026

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
Medline Industries
Generic name (nonproprietary)
cetirizine hcl
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 53329-036_5b88db38-8700-9317-e063-6394a90aae8bSPL ID 5b88db38-8700-9317-e063-6394a90aae8b
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

N453329003605 followed by a unit qualifier and the quantity

Package 53329-0036-05. 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

The FDA listing for this product does not reference a label (SPL) set.

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
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
Cetirizinecetirizine hydrochlorideCetirizine hydrochloride 10 mg/1Tablet, Film coatedOralNorthwind Health Company, LLC51655-194

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Medline Industries (cetirizine hcl) NDC 53329-036 | Med-Code