Prescription drug · ANDA
Azithromycin NDC 50090-5366
Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-5366-0 | 50090536600 | 5 TABLET, FILM COATED in 1 BOTTLE (50090-5366-0)Marketed from Nov 17, 2020 | |
| 50090-5366-1 | 50090536601 | 1 TABLET, FILM COATED in 1 BOTTLE (50090-5366-1)Marketed from Nov 17, 2020 |
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)
- Azithromycin
- Generic name (nonproprietary)
- azithromycin
- Active ingredients
- Azithromycin dihydrate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- A-S Medication Solutions
- 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 50090-5366_8d368b7b-503b-4e04-b13c-ec56f189191fSPL ID 8d368b7b-503b-4e04-b13c-ec56f189191fSPL set ID 77c5e4c6-6d16-40fe-bf36-cb441348f39bRxCUI 248656UNII 5FD1131I7S
- 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
N450090536600followed by a unit qualifier and the quantityPackage 50090-5366-00. 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)
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 ) Urethritis…
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 | 50090-5376 |
| 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 | Proficient Rx LP | 71205-519 |
| 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 |