Prescription drug · ANDA
Azithromycin NDC 55695-003
Azithromycin monohydrate 200 mg/5mL · Powder, For suspension · Oral · STATE HEALTH SERVICES, TEXAS DEPARTMENT OF
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55695-003-00 | 55695000300 | 30 mL in 1 BOTTLE (55695-003-00)Marketed from Dec 28, 2010 | |
| 55695-003-01 | 55695000301 | 15 mL in 1 BOTTLE (55695-003-01)Marketed from Dec 28, 2010 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 200 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 55695-003_1287e725-48d5-e23e-e063-6394a90a96acSPL ID 1287e725-48d5-e23e-e063-6394a90a96acSPL set ID 2b821631-0df2-0fb2-e054-00144ff8d46cRxCUI 141963, 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
N455695000300followed by a unit qualifier and the quantityPackage 55695-0003-00. 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)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for oral suspension USP and other antibacterial drugs, azithromycin for oral suspension USP should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Azithromycin for oral suspension USP is a macrolide antibacterial drug indicated for the treatment of patients with mild to modera…
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 | 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 | Proficient Rx LP | 63187-093 |
| Azithromycin | Azithromycin monohydrate 100 mg/5mL | Powder, For suspensionOral | NuCare Pharmaceuticals,Inc. | 68071-1527 |