Prescription drug · ANDA
Azithromycin NDC 70710-1457
Azithromycin dihydrate 100 mg/5mL · Powder, For suspension · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1457-1 | 70710145701 | 1 BOTTLE in 1 CARTON (70710-1457-1) / 15 mL in 1 BOTTLEMarketed from Aug 6, 2018 |
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 — 100 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211147
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 70710-1457_9a75d659-f8d4-4333-bc16-89ea2693b9edSPL ID 9a75d659-f8d4-4333-bc16-89ea2693b9edSPL set ID 99e5bd22-a721-4e2e-a46c-d61a53c25c3dRxCUI 141963, 308459UNII 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
N470710145701followed by a unit qualifier and the quantityPackage 70710-1457-01. 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 treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: 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 and cervicitis in adults (1.1) Genital ulcer disease in men (1.1) Acute otitis media in pediatric patients (6 months of age and older) (1.2) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) (1.1, 1.2) Pharyngitis/tonsillitis in adults and pediatric pati…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211147
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 200 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-4458 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Redpharm Drug | 67296-2141 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Preferred Pharmaceuticals Inc. | 68788-8246 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-4779 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1460 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1458 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Pharmaceuticals USA Inc. | 70710-1459 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1423 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1422 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1424 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Zydus Lifesciences Limited | 70771-1425 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 71205-216 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-6267 |