Prescription drug · ANDA
levocetirizine dihydrochloride NDC 63629-2533
Levocetirizine dihydrochloride .5 mg/mL · Solution · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2533-1 | 6362925330163629253301 | 1 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLEMarketed from Nov 7, 2011 |
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)
- levocetirizine dihydrochloride
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — .5 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091263
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04SPL ID acc7fd37-12cc-4319-ac53-eb35e3e18d04SPL set ID 628c26f0-f6bb-4658-ba50-8ca04cd859cbRxCUI 855168UNII 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
N463629253301followed by a unit qualifier and the quantityPackage 63629-2533-01. 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 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 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 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 63629-2533
- What is NDC 63629-2533?
- 63629-2533 is the product NDC for levocetirizine dihydrochloride, Levocetirizine dihydrochloride .5 mg/mL solution, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 59 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 | Camber Consumer Care Inc | 69230-321 | 69230-0321-0169230-0321-1069230-0321-31+3 more |
| 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 | 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 | Chain Drug Marketing Association INC | 63868-473 | 63868-0473-35 |
Other NDCs under ANDA 091263
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 |
|---|---|---|---|---|
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride .5 mg/mL | SolutionOral | Padagis Israel Pharmaceuticals Ltd | 45802-680 |
| levocetirizine dihydrochloride | Levocetirizine dihydrochloride .5 mg/mL | SolutionOral | Bryant Ranch Prepack | 72162-1424 |