Prescription drug · ANDA
Azithromycin Dihydrate NDC 50090-4601
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Azithromycin Dihydrate
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 250 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 208250
- Marketing start
- Marketing end
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 50090-4601_e5a7d412-de53-471b-a06e-68b3365865a2SPL ID e5a7d412-de53-471b-a06e-68b3365865a2SPL set ID df9b39b7-d42d-4c4b-b492-9fd228978decRxCUI 308460UNII 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.
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 208250
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 250 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-089 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8800 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4527 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1502 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-182 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2185 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-081 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-430 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | AvPAK | 50268-074 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals Inc. | 68071-3715 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | TAGI Pharma, Inc. | 51224-022 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-046 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0218 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-081 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4160 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-483 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Precision Dose, Inc. | 68094-900 |