Prescription drug · ANDA
Azithromycin (azithromycin monohydrate) NDC 63323-398
Azithromycin monohydrate 500 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-398-10 | 63323039810 | 10 VIAL in 1 TRAY (63323-398-10) / 5 mL in 1 VIAL (63323-398-01)Marketed from Mar 20, 2006 |
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 monohydrate
- Active ingredients
- Azithromycin monohydrate — 500 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065179
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 63323-398_2143a7d1-6575-4d24-8ef4-001ecf2671e2SPL ID 2143a7d1-6575-4d24-8ef4-001ecf2671e2SPL set ID b69917c0-95d5-4b29-b0e3-07054a4fd79fRxCUI 1668238UNII JTE4MNN1MDUPC 0363323398019
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N463323039810followed by a unit qualifier and the quantityPackage 63323-0398-10. 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 injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Azithromycin for injection, USP is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Community-acquired pneumonia in adults ( 1.1 ) Pelvic inflammatory disease ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin for injection, USP and other antibacterial drugs, azithromycin for injection, USP should be used only to treat or prevent infections that are proven or s…
Excerpt only. Read the full label for complete information.