Over-the-counter drug · ANDA
Premier Value Childrens Cetirizine NDC 68016-165
cetirizine hydrochloride · Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Pharmacy Value Alliance LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-165-00 | 68016016500 | 1 BOTTLE in 1 CARTON (68016-165-00) / 120 mL in 1 BOTTLEMarketed from Sep 8, 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)
- Premier Value Childrens CetirizineSuffix: Childrens Cetirizine
- 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 090182
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68016-165_39ad746e-1dd7-f3fb-e063-6394a90a767dSPL ID 39ad746e-1dd7-f3fb-e063-6394a90a767dSPL set ID a4931f0b-86f2-42c5-b2df-b359bb46f44aRxCUI 1014673UNII 64O047KTOAUPC 0840986028632
- 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
N468016016500followed by a unit qualifier and the quantityPackage 68016-0165-00. 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 090182
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 1 mg/mL | SolutionOral | STRATEGIC SOURCING SERVICES LLC | 70677-1236 |
| Childrens Cetirizine Hydrochloride Sugar Free Grapecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | VERITYRX, LLC | 83939-0009 |
| childrens allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Publix Super Markets Inc | 56062-102 |
| Childrens Cetirizine Hydrochloride Sugar Free Grapecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2102 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Chain Drug Consortium, LLC (Premier Value) | 68016-023 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2147 |
| Childrens Cetirizine Hydrochloride Sugar Free Grapecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Proficient Rx LP | 71205-705 |
| Childrens Cetirizine Hydrochloride Sugar Free Grapecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | A-S Medication Solutions | 50090-1103 |
| Equate Childrens Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Wal-Mart Stores Inc | 49035-276 |
| HEB Allergy Reliefcetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | H E B | 37808-102 |
| SIMPLY RIGHT childrens cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Sam's West Inc | 68196-102 |