Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 81469-352
Cetirizine hydrochloride 5 mg/1 · Tablet · Oral · First Nation Group, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81469-352-01 | 8146903520181469035201 | 100 TABLET in 1 BOTTLE (81469-352-01)Marketed from Oct 2, 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)
- Cetirizine Hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- First Nation Group, LLCNDC labeler code 81469
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076047
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 81469-352_5c9ebb06-784f-4ef7-e063-6394a90aaf25SPL ID 5c9ebb06-784f-4ef7-e063-6394a90aaf25
- 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
N481469035201followed by a unit qualifier and the quantityPackage 81469-0352-01. 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 81469-352
- What is NDC 81469-352?
- 81469-352 is the product NDC for Cetirizine Hydrochloride, Cetirizine hydrochloride 5 mg/1 tablet, listed with the FDA by First Nation Group, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride.
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- First Nation Group, LLC, NDC labeler code 81469. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Cetirizine Hydrochloride?
- 107 other product NDCs are listed under this name. See all Cetirizine Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Cetirizine Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 | 81469-0353-0181469-0353-0381469-0353-05+1 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-017 | 48433-0017-20 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Advagen Pharma Ltd., | 72888-480 | 72888-0480-01 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4072 | 68788-4072-0368788-4072-0668788-4072-09 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Bionpharma Inc. | 69452-426 | 69452-0426-5569452-0426-88 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-357 | 57237-0357-1257237-0357-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-358 | 57237-0358-1257237-0358-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-0261037-0480-0361037-0480-04+2 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-2261037-0480-2361037-0480-24+2 more |
| Cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, CoatedOral | Advanced Rx LLC | 80513-731 | 80513-0731-0580513-0731-12 |
Other NDCs under ANDA 076047
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 |
|---|---|---|---|---|
| Cetirizine HClcetirizine | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | GERI-CARE PHARMACEUTICAL CORP | 57896-992 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-458 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 |
| Cetirizine Hydrochloride 10 mg | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Contract Pharmacal Corp. | 10267-3579 |
| Dr Simi Cetirizine Hydrochloride 10 mgcetirizine hydrochloride 10 mg | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-203 |