Prescription drug · ANDA
levocetirizine dihydrochloride NDC 71335-0940
Levocetirizine dihydrochloride 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0940-1 | 71335094001 | 30 TABLET in 1 BOTTLE (71335-0940-1)Marketed from Aug 30, 2018 | |
| 71335-0940-2 | 71335094002 | 90 TABLET in 1 BOTTLE (71335-0940-2)Marketed from Aug 30, 2018 | |
| 71335-0940-3 | 71335094003 | 28 TABLET in 1 BOTTLE (71335-0940-3)Marketed from Aug 30, 2018 | |
| 71335-0940-4 | 71335094004 | 60 TABLET in 1 BOTTLE (71335-0940-4)Marketed from Aug 30, 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)
- levocetirizine dihydrochloride
- Generic name (nonproprietary)
- levocetirizine dihydrochloride
- Active ingredients
- Levocetirizine dihydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203646
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-0940_c56f1c2a-3e1a-4e1a-9b6c-855351030d80SPL ID c56f1c2a-3e1a-4e1a-9b6c-855351030d80SPL set ID 34541530-ae3b-4247-b08c-cd1c13e2e6a1RxCUI 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
N471335094001followed by a unit qualifier and the quantityPackage 71335-0940-01. 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 tablets are 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.