Prescription drug · ANDA
Azithromycin Dihydrate NDC 70518-3168
Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3168-1 | 70518316801 | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3168-1)Marketed from Jan 19, 2022 |
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 Dihydrate
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208249
- Marketing start
- Marketing end
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 70518-3168_583b5aca-16da-cbd8-e063-6394a90ae054SPL ID 583b5aca-16da-cbd8-e063-6394a90ae054SPL set ID c7ed6985-1d1d-48af-9df8-64b12821789eRxCUI 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
N470518316801followed by a unit qualifier and the quantityPackage 70518-3168-01. 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)
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 208249
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 Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8773 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-090 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Advanced Rx of Tennessee, LLC | 80425-0220 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-042 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-3661 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4700 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | TAGI Pharma, Inc. | 51224-122 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-153 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7506 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1607 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-491 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4105 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-445 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Health Department, Oklahoma State | 83112-501 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7299 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7298 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2581 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Precision Dose, Inc. | 68094-799 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-1942 |