Prescription drug · ANDA
Levocetirizine Dihydrochloride NDC 50090-1430
Levocetirizine dihydrochloride 5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1430-0 | 50090143000 | 30 TABLET in 1 BOTTLE (50090-1430-0)Marketed from Nov 28, 2014 | |
| 50090-1430-1 | 50090143001 | 90 TABLET in 1 BOTTLE (50090-1430-1)Marketed from May 11, 2015 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-1430_26d1cd0e-482f-4296-961f-46c311479178SPL ID 26d1cd0e-482f-4296-961f-46c311479178SPL set ID d8b4b326-8be1-4404-9db7-636d86933139RxCUI 855172UNII 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
N450090143000followed by a unit qualifier and the quantityPackage 50090-1430-00. 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)
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 | Camber Pharmaceuticals, Inc. | 31722-551 |
| 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 |