Over-the-counter drug · ANDA
Cetirizine Hydrochloride Tablets,10 mg (Cetirizine hydrochloride) NDC 51655-842
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-842-26 | 5165508422651655084226 | 90 TABLET in 1 BOTTLE, PLASTIC (51655-842-26)Marketed from Feb 7, 2023 | |
| 51655-842-52 | 5165508425251655084252 | 30 TABLET in 1 BOTTLE, PLASTIC (51655-842-52)Marketed from Apr 7, 2023 | |
| 51655-842-60 | 5165508426051655084260 | 100 TABLET in 1 BOTTLE, PLASTIC (51655-842-60)Marketed from Mar 30, 2023 | |
| 51655-842-84 | 5165508428451655084284 | 14 TABLET in 1 BOTTLE, PLASTIC (51655-842-84)Marketed from Mar 10, 2023 |
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
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Northwind Health Company, LLCNDC labeler code 51655
- 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 51655-842_4bbb94e5-ada2-ab07-e063-6394a90a1b01SPL ID 4bbb94e5-ada2-ab07-e063-6394a90a1b01SPL set ID f756d3b1-d2e4-3705-e053-6294a90aa380RxCUI 1014678UNII 64O047KTOA
- 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
N451655084226followed by a unit qualifier and the quantityPackage 51655-0842-26. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 51655-842
- What is NDC 51655-842?
- 51655-842 is the product NDC for Cetirizine Hydrochloride Tablets,10 mg, Cetirizine hydrochloride 10 mg/1 tablet, listed with the FDA by Northwind Health Company, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride Tablets,10 mg (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Northwind Health Company, LLC, NDC labeler code 51655. 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 Tablets,10 mg?
- 2 other product NDCs are listed under this name. See all Cetirizine Hydrochloride Tablets,10 mg 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 Tablets,10 mg 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 Tablets,10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | TIME CAP LABORATORIES, INC. | 49483-692 | 49483-0692-0149483-0692-2049483-0692-50+1 more |
| Cetirizine Hydrochloride Tablets, 10 mgcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-220 | 25000-0220-0325000-0220-0825000-0220-14+2 more |
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 |
|---|---|---|---|---|
| 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 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | WALGREENS | 0363-1794 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | BETTER LIVING BRANDS, LLC | 21130-712 |
| 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 | MARKSANS PHARMA LIMITED | 25000-220 |
| Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | MARKSANS PHARMA LIMITED | 25000-160 |
| 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 | TIME CAP LABORATORIES, INC. | 49483-692 |