Prescription drug · ANDA
Azithromycin NDC 71205-519
Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-519-03 | 71205051903 | 1 BLISTER PACK in 1 CARTON (71205-519-03) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 4, 2021 | |
| 71205-519-30 | 71205051930 | 30 TABLET, FILM COATED in 1 BOTTLE (71205-519-30)Marketed from Jan 4, 2021 |
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)
- Azithromycin
- Generic name (nonproprietary)
- azithromycin
- Active ingredients
- Azithromycin dihydrate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207398
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 71205-519_8a140f7c-4dc7-454d-9ff9-473f4306a649SPL ID 8a140f7c-4dc7-454d-9ff9-473f4306a649SPL set ID 25f2d819-ae38-4061-a897-bbcfce3739bfRxCUI 248656, 749780UNII 5FD1131I7SUPC 0371205519032
- Pharmacologic class
- Macrolide Antimicrobial
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
N471205051903followed by a unit qualifier and the quantityPackage 71205-0519-03. 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)
Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. Recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see Dosage and Administration (2) ] Azithromycin is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Acute bacterial exacerbations of chronic bronchitis in adults ( 1.1 ) • Acute bacterial sinusitis in adults ( 1.1 ) • Uncomplicated skin and skin structure infections in adults ( 1.1 ) • Ur…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207398
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 |
|---|---|---|---|---|
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5082 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5366 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5376 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8013 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-8017 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-7598 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3508 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4976 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2669 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-015 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-8251 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-642 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1945 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5058 |