Over-the-counter drug · NDA
Xyzal Allergy 24HR (Levocetirizine dihydrochloride) NDC 41167-3510
Levocetirizine dihydrochloride 5 mg/1 · Tablet · Oral · Chattem, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41167-3510-0 | 41167351000 | 1 BLISTER PACK in 1 CARTON (41167-3510-0) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 10, 2017 | |
| 41167-3510-1 | 41167351001 | 1 BOTTLE in 1 CARTON (41167-3510-1) / 35 TABLET in 1 BOTTLEMarketed from Mar 10, 2017 | |
| 41167-3510-2 | 41167351002 | 1 BOTTLE in 1 CARTON (41167-3510-2) / 55 TABLET in 1 BOTTLEMarketed from Mar 10, 2017 | |
| 41167-3510-3 | 41167351003 | 1 BOTTLE in 1 CARTON (41167-3510-3) / 80 TABLET in 1 BOTTLEMarketed from Mar 10, 2017 | |
| 41167-3510-4 | 41167351004 | 2 BOTTLE in 1 CARTON (41167-3510-4) / 55 TABLET in 1 BOTTLEMarketed from Mar 10, 2017 | |
| 41167-3510-5 | 41167351005 | 1 BOTTLE in 1 CARTON (41167-3510-5) / 45 TABLET in 1 BOTTLEMarketed from Jan 4, 2024 | |
| 41167-3510-6 | 41167351006 | 1 BLISTER PACK in 1 CARTON (41167-3510-6) / 5 TABLET in 1 BLISTER PACKMarketed from Nov 15, 2018 |
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 Allergy 24HR
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chattem, Inc.NDC labeler code 41167
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209089
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41167-3510_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5SPL ID f43bc46c-c507-4ccf-9b93-17eaeebf4ed5SPL set ID 8be45c2a-1eca-4a00-81b9-f7babdbdcd41RxCUI 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
N441167351000followed by a unit qualifier and the quantityPackage 41167-3510-00. 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 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 41167-3510
- What is NDC 41167-3510?
- 41167-3510 is the product NDC for Xyzal Allergy 24HR (levocetirizine dihydrochloride), Levocetirizine dihydrochloride 5 mg/1 tablet, listed with the FDA by Chattem, Inc.. It has 7 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xyzal Allergy 24HR (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 Allergy 24HR?
- 2 other product NDCs are listed under this name. See all Xyzal Allergy 24HR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xyzal Allergy 24HR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xyzal Allergy 24HRlevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Chattem, Inc. | 41167-3513 | 41167-3513-04 |
| Xyzal Allergy 24HRlevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Chattem, Inc. | 41167-3511 | 41167-3511-0241167-3511-0841167-3511-09 |
Other NDCs under NDA 209089
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 |
|---|---|---|---|---|
| Xyzal Allergy 24HRlevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Chattem, Inc. | 41167-3511 |
| Xyzal Allergy 24HRlevocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Chattem, Inc. | 41167-3513 |