Prescription drug · NDA
Xyzal (Levocetirizine dihydrochloride) NDC 41167-5804
Levocetirizine dihydrochloride .5 mg/mL · Solution · Oral · Chattem, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41167-5804-5 | 41167580405 | 1 BOTTLE in 1 CARTON (41167-5804-5) / 148 mL in 1 BOTTLEMarketed from Jul 24, 2017 |
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)
- Xyzal
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — .5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chattem, Inc.NDC labeler code 41167
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022064
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41167-5804_87a83f00-5abf-437d-af13-394c22964050SPL ID 87a83f00-5abf-437d-af13-394c22964050SPL set ID 1673f7ff-0c7c-4403-86cf-c05eb1475222RxCUI 855168, 855170, 855172, 855174UNII 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
N441167580405followed by a unit qualifier and the quantityPackage 41167-5804-05. 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)
XYZAL is a histamine H 1 -receptor antagonist indicated for: The relief of symptoms associated with perennial allergic rhinitis ( 1.1 ) The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.1 Perennial Allergic Rhinitis XYZAL is indicated for the relief of symptoms associated with perennial allergic rhinitis in children 6 months to 2 years of age. 1.2 Chronic Idiopathic Urticaria XYZAL is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.
Excerpt only. Read the full label for complete information.
About NDC 41167-5804
- What is NDC 41167-5804?
- 41167-5804 is the product NDC for Xyzal (levocetirizine dihydrochloride), Levocetirizine dihydrochloride .5 mg/mL solution, listed with the FDA by Chattem, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xyzal (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 Xyzal?
- 1 other product NDC are listed under this name. See all Xyzal NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xyzal products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xyzallevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Chattem, Inc. | 41167-5803 | 41167-5803-09 |
Other NDCs under NDA 022064
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 |
|---|---|---|---|---|
| Xyzallevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Chattem, Inc. | 41167-5803 |