Prescription drug · ANDA
Desloratadine NDC 71335-1000
Desloratadine 5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1000-1 | 71335100001 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1000-1)Marketed from Nov 13, 2018 | |
| 71335-1000-2 | 71335100002 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1000-2)Marketed from Apr 9, 2024 | |
| 71335-1000-3 | 71335100003 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1000-3)Marketed from Apr 9, 2024 |
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)
- Desloratadine
- Generic name (nonproprietary)
- desloratadine
- Active ingredients
- Desloratadine — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078352
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 71335-1000_b62a5a2c-ad72-4010-a6b7-b0f2593011c5SPL ID b62a5a2c-ad72-4010-a6b7-b0f2593011c5SPL set ID f84c8de3-a7d3-4e8b-bfb6-04259e79450aRxCUI 349420UNII FVF865388R
- 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
N471335100001followed by a unit qualifier and the quantityPackage 71335-1000-01. 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)
Desloratadine tablets are histamine-1 (H1) receptor antagonist indicated for: Seasonal Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.1 ) Perennial Allergic Rhinitis: relief of nasal and non-nasal symptoms in patients 12 years of age and older. ( 1.2 ) 1.1 Seasonal Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of seasonal allergic rhinitis in patients 12 years of age and older. 1.2 Perennial Allergic Rhinitis Desloratadine tablets are indicated for the relief of the nasal and non-nasal symptoms of perennial allergic rhinitis in patients 12 years of age and older.…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078352
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 |
|---|---|---|---|---|
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6724 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-153 |
| Desloratadine | Desloratadine 5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4794 |