Over-the-counter drug · ANDA
Childrens Cetirizine Hydrochloride (Cetirizine hydrochloride) NDC 68016-023
Cetirizine hydrochloride 5 mg/5mL · Solution · Oral · Chain Drug Consortium, LLC (Premier Value)
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-023-43 | 6801600234368016002343 | 1 BOTTLE in 1 CARTON (68016-023-43) / 120 mL in 1 BOTTLEMarketed from Apr 22, 2008 |
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 Cetirizine Hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride
- Active ingredients
- Cetirizine hydrochloride — 5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chain Drug Consortium, LLC (Premier Value)NDC labeler code 68016
- 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 68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4SPL ID c067a0f7-cadb-42cb-9bd4-6b901aec98c4SPL set ID b47b0c8b-59d5-4e17-95be-a992c6861ee7RxCUI 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
N468016002343followed by a unit qualifier and the quantityPackage 68016-0023-43. 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 itchy, watery eyes sneezing itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 68016-023
- What is NDC 68016-023?
- 68016-023 is the product NDC for Childrens Cetirizine Hydrochloride, Cetirizine hydrochloride 5 mg/5mL solution, listed with the FDA by Chain Drug Consortium, LLC (Premier Value). It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Cetirizine Hydrochloride (Cetirizine Hydrochloride).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Chain Drug Consortium, LLC (Premier Value), NDC labeler code 68016. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Cetirizine Hydrochloride?
- 9 other product NDCs are listed under this name. See all Childrens 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 Childrens 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) |
|---|---|---|---|---|---|
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALMART INC. | 79903-406 | 79903-0406-10 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2147 | 51672-2147-0151672-2147-08 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Preferred Pharmaceuticals Inc. | 68788-8188 | 68788-8188-01 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | CVS Pharmacy, Inc. | 69842-961 | 69842-0961-76 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | WALGREEN CO. | 0363-4025 | 00363-4025-76 |
| Childrens Cetirizine Hydrochloridecetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Orally disintegratingOral | Aurohealth LLC | 58602-856 | 58602-0856-1458602-0856-7558602-0856-76 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Major Pharmaceuticals | 0904-6765 | 00904-6765-20 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | ATLANTIC BIOLOGICALS CORP. | 17856-6765 | 17856-6765-0117856-6765-0317856-6765-09 |
| childrens cetirizine hydrochloridecetirizine hcl | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Proficient Rx LP | 71205-722 | 71205-0722-04 |
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 allergycetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Publix Super Markets Inc | 56062-102 |
| 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 | A-S Medication Solutions | 50090-1103 |
| Childrens Cetirizine Hydrochloride Sugar Free Grapecetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Sun Pharmaceutical Industries, Inc. | 51672-2102 |
| 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 | VERITYRX, LLC | 83939-0009 |
| 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 |
| Premier Value Childrens Cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Pharmacy Value Alliance LLC | 68016-165 |
| SIMPLY RIGHT childrens cetirizinecetirizine hydrochloride | Cetirizine hydrochloride 5 mg/5mL | SolutionOral | Sam's West Inc | 68196-102 |