Over-the-counter drug · ANDA
Cetirizine Hydrochloride (Cetirizine hydrochloride tablets) NDC 68788-8435
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8435-3 | 6878884350368788843503 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8435-3)Marketed from Apr 27, 2023 | |
| 68788-8435-6 | 6878884350668788843506 | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8435-6)Marketed from Apr 27, 2023 | |
| 68788-8435-9 | 6878884350968788843509 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8435-9)Marketed from Apr 27, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Labeler
- Preferred Pharmaceuticals Inc.NDC labeler code 68788
- 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 68788-8435_8efeffe6-f264-4a44-a348-63a33f9c6d25SPL ID 8efeffe6-f264-4a44-a348-63a33f9c6d25SPL set ID 14a885e5-5e75-4a18-b5bc-6aaa748712dbRxCUI 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
N468788843503followed by a unit qualifier and the quantityPackage 68788-8435-03. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itchy, watery eyes 4. itching of the nose or throat .
Excerpt only. Read the full label for complete information.
About NDC 68788-8435
- What is NDC 68788-8435?
- 68788-8435 is the product NDC for Cetirizine Hydrochloride (cetirizine hydrochloride tablets), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cetirizine Hydrochloride (Cetirizine Hydrochloride Tablets).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Preferred Pharmaceuticals Inc., NDC labeler code 68788. 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 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-352 | 81469-0352-01 |
| 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 | 61037-0480-2261037-0480-2361037-0480-24+2 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-0261037-0480-0361037-0480-04+2 more |
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 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 | VERITYRX, LLC | 83939-0004 |
| cetirizine hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services LLC | 70677-1007 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-045 |
| 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 | Dr. Reddy's Laboratories Inc. | 43598-183 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-811 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-709 |
| 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 | Northwind Health Company, LLC | 51655-801 |