Over-the-counter drug · NDA
Childrens Xyzal Allergy (Levocetirizine dihydrochloride) NDC 41167-3533
Levocetirizine dihydrochloride 2.5 mg/5mL · Solution · Oral · Chattem, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41167-3533-0 | 41167353300 | 1 BOTTLE in 1 CARTON (41167-3533-0) / 148 mL in 1 BOTTLEMarketed from Jan 4, 2024 | |
| 41167-3533-1 | 41167353301 | 1 BOTTLE in 1 CARTON (41167-3533-1) / 295 mL in 1 BOTTLEMarketed from Jan 1, 2026 |
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)
- Childrens Xyzal Allergy
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — 2.5 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chattem, Inc.NDC labeler code 41167
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209090
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41167-3533_3ce97c09-ae27-48cf-9413-0c7190a1fb94SPL ID 3ce97c09-ae27-48cf-9413-0c7190a1fb94SPL set ID a33f2704-d350-428b-b467-91f4775ce17fRxCUI 855168, 855170UNII SOD6A38AGA
- 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
N441167353300followed by a unit qualifier and the quantityPackage 41167-3533-00. 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)
Use s temporarily relieves these symptoms due to hay fever or other respiratory allergies: ■ runny nose ■ sneezing ■ itchy, watery eyes ■ itching of the nose or throat
Excerpt only. Read the full label for complete information.
About NDC 41167-3533
- What is NDC 41167-3533?
- 41167-3533 is the product NDC for Childrens Xyzal Allergy (levocetirizine dihydrochloride), Levocetirizine dihydrochloride 2.5 mg/5mL solution, listed with the FDA by Chattem, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Xyzal Allergy (Levocetirizine dihydrochloride).
- What is the active ingredient?
- Levocetirizine dihydrochloride.
- Who is the labeler?
- Chattem, Inc., NDC labeler code 41167. 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 Xyzal Allergy?
- 1 other product NDC are listed under this name. See all Childrens Xyzal Allergy NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Childrens Xyzal Allergy 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 Xyzal Allergylevocetirizine dihydrochloride | Levocetirizine dihydrochloride 2.5 mg/5mL | SolutionOral | Chattem, Inc. | 41167-3535 | 41167-3535-0041167-3535-01 |
Other NDCs under NDA 209090
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 |
|---|---|---|---|---|
| Childrens Xyzal Allergylevocetirizine dihydrochloride | Levocetirizine dihydrochloride 2.5 mg/5mL | SolutionOral | Chattem, Inc. | 41167-3535 |