Over-the-counter drug · ANDA
Cetirizine Hydrochloride (cetirizine hydrochloride tablets) NDC 43598-811
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-811-05 | 43598081105 | 1 BOTTLE in 1 CARTON (43598-811-05) / 500 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 17, 2018 | |
| 43598-811-12 | 43598081112 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-811-12)Marketed from Sep 3, 2019 | |
| 43598-811-13 | 43598081113 | 300 TABLET, FILM COATED in 1 BOTTLE (43598-811-13)Marketed from Sep 3, 2019 | |
| 43598-811-15 | 43598081115 | 500 TABLET, FILM COATED in 1 BOTTLE (43598-811-15)Marketed from Sep 3, 2019 | |
| 43598-811-30 | 43598081130 | 1 BOTTLE in 1 CARTON (43598-811-30) / 300 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 17, 2018 | |
| 43598-811-90 | 43598081190 | 1 BOTTLE in 1 CARTON (43598-811-90) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from Dec 17, 2018 |
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 tablets
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078343
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 43598-811_adfee3f6-660a-305c-2cf4-bd509acfad36SPL ID adfee3f6-660a-305c-2cf4-bd509acfad36SPL set ID e4eca4df-9ad8-b7c4-b512-bfaed5673789RxCUI 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
N443598081105followed by a unit qualifier and the quantityPackage 43598-0811-05. 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
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 078343
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 Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-045 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0004 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9612 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-709 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-351 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-801 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-183 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8435 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Discount Drug Mart, Inc | 53943-519 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-699 |
| cetirizine hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1007 |