Prescription drug · ANDA
Azithromycin NDC 68788-8675
Azithromycin monohydrate 100 mg/5mL · Powder, For suspension · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8675-1 | 68788867501 | 15 mL in 1 BOTTLE (68788-8675-1)Marketed from May 23, 2024 |
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 monohydrate — 100 mg/5mL
- Dosage form
- Powder, For suspension
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065246
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 68788-8675_b24a545d-b889-455f-be44-e9d2b9215583SPL ID b24a545d-b889-455f-be44-e9d2b9215583SPL set ID ac327054-21ab-401c-a27a-48259db18f89RxCUI 308459UNII JTE4MNN1MD
- 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
N468788867501followed by a unit qualifier and the quantityPackage 68788-8675-01. 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 for oral suspension 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 for oral suspension is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: • Acute bacterial exacerbations of chronic bronchitis in adults () • Acute bacterial sinusitis in adults () • Uncomplicated skin and skin structure in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065246
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 100 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-1868 |
| Azithromycin | Azithromycin monohydrate 200 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-2026 |
| Azithromycin | Azithromycin monohydrate 100 mg/5mL | Powder, For suspensionOral | Teva Pharmaceuticals USA, Inc. | 0093-2027 |
| Azithromycin | Azithromycin monohydrate 100 mg/5mL | Powder, For suspensionOral | STATE HEALTH SERVICES, TEXAS DEPARTMENT OF | 55695-002 |
| Azithromycin | Azithromycin monohydrate 200 mg/5mL | Powder, For suspensionOral | STATE HEALTH SERVICES, TEXAS DEPARTMENT OF | 55695-003 |
| Azithromycin | Azithromycin monohydrate 200 mg/5mL | Powder, For suspensionOral | Proficient Rx LP | 63187-093 |
| Azithromycin | Azithromycin monohydrate 100 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1527 |