Over-the-counter drug · ANDA
Cetirizine Hydrochloride NDC 10135-762
Cetirizine hydrochloride 10 mg/1 · Tablet · Oral · Marlex Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-762-01 | 10135076201 | 100 TABLET in 1 BOTTLE (10135-762-01)Marketed from Oct 1, 2022 | |
| 10135-762-03 | 10135076203 | 300 TABLET in 1 BOTTLE (10135-762-03)Marketed from Oct 1, 2022 | |
| 10135-762-05 | 10135076205 | 500 TABLET in 1 BOTTLE (10135-762-05)Marketed from Oct 1, 2022 | |
| 10135-762-30 | 10135076230 | 30 TABLET in 1 BOTTLE (10135-762-30)Marketed from Oct 1, 2022 | |
| 10135-762-90 | 10135076290 | 90 TABLET in 1 BOTTLE (10135-762-90)Marketed from Oct 1, 2022 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077498
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 10135-762_3f7dc523-2934-780a-e063-6294a90a837fSPL ID 3f7dc523-2934-780a-e063-6294a90a837fSPL set ID eb917099-fecf-6b55-e053-2995a90aaafaRxCUI 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
N410135076201followed by a unit qualifier and the quantityPackage 10135-0762-01. 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
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.
Other NDCs under ANDA 077498
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 Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Proficient Rx LP | 63187-110 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Sportpharm LLC | 85766-205 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Publix Super Markets Inc | 56062-939 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Valu Merchandisers Company | 63941-939 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-821 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Ohm Laboratories Inc. | 51660-939 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | FAMILY DOLLAR SERVICES, INC | 55319-939 |
| Quality Choice Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Chain Drug Marketing Association Inc. | 63868-132 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Chain Drug Consortium, LLC | 68016-939 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 55289-995 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | LIDL US, LLC | 71141-133 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2571 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | Marc Glassman, Inc. | 68998-939 |