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| 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
- 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
N453329003605followed by a unit qualifier and the quantityPackage 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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5510 |
| Equaline all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | United Natural Foods, Inc. dba UNFI | 41163-458 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 71205-207 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0003 |
| Exchange select all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Army & Air Force Exchange Service | 55301-076 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Walgreen Company | 0363-4101 |
| Berkley And Jensen All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | BJWC | 68391-400 |
| signature care allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safeway | 21130-090 |
| Members Mark Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sam's West Inc | 68196-413 |
| allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | H E B | 37808-583 |
| 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 |
| 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 |
| Up and Up Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Target Corporation | 11673-502 |
| Allergy Relief Indoor and Outdoor Allergiescetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | CVS Pharmacy | 59779-458 |
| basic care all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Amazon.com Services LLC | 72288-411 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7510 |
| Good Sense all day allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc | 68788-4023 |
| Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2162 |
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