What is NDC 53329-036?

53329-036 is the product NDC for Medline Industries (cetirizine hcl), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Medline Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Medline Industries (Cetirizine HCl).

Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Medline Industries?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Medline Industries NDC 53329-036 | National Drug Code

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 NDC	11-digit (billing)	Package	Copy
53329-036-05	5332900360553329003605	1 BOTTLE in 1 CARTON (53329-036-05) / 30 TABLET, FILM COATED in 1 BOTTLE (53329-036-33)Marketed from Aug 28, 2026
53329-036-09	5332900360953329003609	1 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
Labeler: Medline Industries, LPNDC labeler code 53329
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078336
Marketing start: Aug 28, 2026
Listing expires: Dec 31, 2027
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.

About NDC 53329-036

What is NDC 53329-036?: 53329-036 is the product NDC for Medline Industries (cetirizine hcl), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Medline Industries, LP. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Medline Industries (Cetirizine HCl).
What is the active ingredient?: Cetirizine hydrochloride.
Who is the labeler?: Medline Industries, LP, NDC labeler code 53329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Medline Industries?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

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
Product	Strength	Form · route	Labeler	Product NDC
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6717
signature care allergy reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Safeway	21130-090
Good Sense all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7064
Exchange select all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Army & Air Force Exchange Service	55301-076
Good Sense all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-7065
Members Mark Allergy Reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Sam's West Inc	68196-413
Berkley And Jensen All Day Allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	BJWC	68391-400
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	VERITYRX, LLC	83939-0003
Equaline all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	United Natural Foods, Inc. dba UNFI	41163-458
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-5510
kirkland signature aller tec allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Costco Wholesale Company	63981-458
dg health all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Dolgencorp Inc	55910-458
allergy reliefcetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Walgreen Company	0363-4101
basic care all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Amazon.com Services LLC	72288-411
Allergy Relief Indoor and Outdoor Allergiescetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	CVS Pharmacy	59779-458
Cetirizinecetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2162
24 hour allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Meijer Distribution Inc	41250-458
all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Rite Aid Corporation	11822-1002
cetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	72162-2173
Good Sense all day allergycetirizine hydrochloride	Cetirizine hydrochloride 10 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc	68788-4023

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Medline Industries (Cetirizine hcl) NDC 53329-036