Over-the-counter drug · ANDA
Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) NDC 25000-160
cetirizine hydrochloride · Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · MARKSANS PHARMA LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25000-160-03 | 25000016003 | 1 BOTTLE in 1 CARTON (25000-160-03) / 30 TABLET in 1 BOTTLEMarketed from Apr 10, 2025 | |
| 25000-160-14 | 25000016014 | 1000 TABLET in 1 BOTTLE (25000-160-14)Marketed from Apr 10, 2025 | |
| 25000-160-81 | 25000016081 | 1 BLISTER PACK in 1 CARTON (25000-160-81) / 14 TABLET in 1 BLISTER PACKMarketed from Apr 10, 2025 |
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)
- Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- MARKSANS PHARMA LIMITED
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078933
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 25000-160_172d56b9-ba90-4e1b-934a-f75307564ea3SPL ID 172d56b9-ba90-4e1b-934a-f75307564ea3SPL set ID 652b0c65-a3f2-4454-9cf2-51a3389282ccRxCUI 1014676, 1014678UNII 64O047KTOAUPC 0325000160814, 0325000219147, 0325000219086, 0325000160036, 0325000160142, 0325000220785, 0325000220037, 0325000220082, 0325000219031, 0325000220143, 0325000220815
- 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
N425000016003followed by a unit qualifier and the quantityPackage 25000-0160-03. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 078933
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 |
|---|---|---|---|---|
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-712 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | WALGREENS | 0363-1794 |
| Cetirizine Hydrochloride Tablets, 5 mgcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-219 |
| Cetirizine Hydrochloride Tablets, 10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-220 |
| Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-842 |
| All Day Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | DOLGENCORP, INC. | 55910-269 |
| Allergycetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Kroger Company | 41226-692 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-682 |
| Cetirizine Hydrochloride Tablets,10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-692 |