Over-the-counter drug · ANDA
Childrens Cetirzine (cetirizine hydrochloride) NDC 68016-106
Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Pharmacy Value Alliance LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-106-08 | 68016010608 | 1 BOTTLE in 1 CARTON (68016-106-08) / 118 mL in 1 BOTTLEMarketed from May 20, 2011 |
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)
- Childrens CetirzineSuffix: Cetirzine
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Pharmacy Value Alliance LLC
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201546
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68016-106_51b02412-ebbd-4045-8af4-4b8b8e90daf4SPL ID 51b02412-ebbd-4045-8af4-4b8b8e90daf4SPL set ID 6b22f568-7ebd-4479-b764-6e5481d8c15aRxCUI 1014673UNII 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
N468016010608followed by a unit qualifier and the quantityPackage 68016-0106-08. 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 201546
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 |
|---|---|---|---|---|
| Wal-Zyr All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | WALGREEN COMPANY | 0363-2106 |
| Childrens Allergycetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Publix Super Markets Inc | 56062-106 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2106 |
| All Day Allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Amerisource Bergen | 46122-101 |
| Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Wal-Mart Stores Inc | 49035-106 |
| Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | H E B | 37808-106 |
| Rite Aid childrens allergy reliefcetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rite Aid Corporation | 11822-2106 |