Prescription drug · ANDA
Levocetirizine Dihydrochloride NDC 31722-551
Levocetirizine dihydrochloride 5 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-551-05 | 31722055105 | 500 TABLET in 1 BOTTLE (31722-551-05)Marketed from Jun 29, 2012 | |
| 31722-551-10 | 31722055110 | 1000 TABLET in 1 BOTTLE (31722-551-10)Marketed from Jun 29, 2012 | |
| 31722-551-18 | 31722055118 | 180 TABLET in 1 BOTTLE (31722-551-18)Marketed from Jun 29, 2012 | |
| 31722-551-30 | 31722055130 | 30 TABLET in 1 BOTTLE (31722-551-30)Marketed from Jun 29, 2012 | |
| 31722-551-90 | 31722055190 | 90 TABLET in 1 BOTTLE (31722-551-90)Marketed from Jun 29, 2012 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091264
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 31722-551_40ccc1d7-149b-e682-e063-6394a90a1d37SPL ID 40ccc1d7-149b-e682-e063-6394a90a1d37SPL set ID dd407f8f-140d-489f-b8c5-f6602d87e247RxCUI 855172UNII SOD6A38AGAUPC 0331722551304
- 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
N431722055105followed by a unit qualifier and the quantityPackage 31722-0551-05. 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)
Levocetirizine dihydrochloride is a histamine H 1 -receptor antagonist indicated for: • The treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria ( 1.2 ) 1.2 Chronic Idiopathic Urticaria Levocetirizine dihydrochloride tablets are indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091264
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/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-023 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-148 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-1430 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0789 |
| Levocetirizine Dihydrochloride | Levocetirizine dihydrochloride 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-6979 |