Prescription drug · ANDA
Levocetirizine Dihydrochloride NDC 62135-917
Levocetirizine dihydrochloride .5 mg/mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-917-38 | 62135091738 | 148 mL in 1 BOTTLE (62135-917-38)Marketed from Aug 30, 2022 |
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)
- Levocetirizine Dihydrochloride
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — .5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204599
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 62135-917_0782ae1c-d903-d465-e063-6294a90a6676SPL ID 0782ae1c-d903-d465-e063-6294a90a6676SPL set ID b56652ad-2cf8-4ed0-bb66-0e832772c792RxCUI 855168UNII SOD6A38AGAUPC 0362135917388
- 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
N462135091738followed by a unit qualifier and the quantityPackage 62135-0917-38. 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)
Levocetirizine dihydrochloride oral solution, 2.5 mg/5 mL (0.5 mg/mL) 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 Levocetirizine dihydrochloride oral solution 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 Levocetirizine dihydrochloride oral solution is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children…
Excerpt only. Read the full label for complete information.
About NDC 62135-917
- What is NDC 62135-917?
- 62135-917 is the product NDC for Levocetirizine Dihydrochloride, Levocetirizine dihydrochloride .5 mg/mL solution, listed with the FDA by Chartwell RX, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levocetirizine Dihydrochloride.
- What is the active ingredient?
- Levocetirizine dihydrochloride.
- Who is the labeler?
- Chartwell RX, LLC, NDC labeler code 62135. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levocetirizine Dihydrochloride?
- 57 other product NDCs are listed under this name. See all Levocetirizine Dihydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levocetirizine Dihydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Farmacias De Similares TX LLC | 85786-206 | 85786-0206-30 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8810 | 68788-8810-0168788-8810-0368788-8810-06+1 more |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-148 | 51655-0148-52 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7934 | 68788-7934-0168788-7934-0368788-7934-06+1 more |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-564 | 51655-0564-52 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-152 | 85766-0152-35 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Chain Drug Marketing Association INC | 63868-473 | 63868-0473-35 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | SAM'S WEST INC | 68196-406 | 68196-0406-20 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | BJWC (Berkley & Jensen / BJ'S) | 68391-955 | 68391-0955-11 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | Tablet, CoatedOral | Rite Aid Corporation | 11822-5252 | 11822-5252-0111822-5252-07 |