Prescription drug · ANDA
Azithromycin NDC 50090-1868
Azithromycin dihydrate 100 mg/5mL · Powder, For suspension · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-1868-0 | 50090186800 | 15 mL in 1 BOTTLE (50090-1868-0)Marketed from Jun 10, 2015 |
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
- Labeler
- A-S Medication Solutions
- 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 50090-1868_4ceb10f9-5c4f-4b5b-be5a-e9e58820558eSPL ID 4ceb10f9-5c4f-4b5b-be5a-e9e58820558eSPL set ID f97d2e7e-ccfd-4f04-85ba-549b37f6aa7bRxCUI 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
N450090186800followed by a unit qualifier and the quantityPackage 50090-1868-00. 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 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 ( 1.1 ) Acute bacterial sinusitis in adults ( 1.1 ) Uncomplicated skin and skin structur…
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 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 | Preferred Pharmaceuticals Inc. | 68788-8675 |
| 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 |