Prescription drug · ANDA
azithromycin NDC 82804-214
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-214-06 | 82804021406 | 6 TABLET, FILM COATED in 1 BLISTER PACK (82804-214-06)Marketed from Apr 7, 2025 |
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 dihydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065398
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 82804-214_25bc2e78-9d0d-41c6-a55e-a267d4457967SPL ID 25bc2e78-9d0d-41c6-a55e-a267d4457967SPL set ID 25bc2e78-9d0d-41c6-a55e-a267d4457967RxCUI 308460, 749783UNII 5FD1131I7SUPC 0382804214068
- 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
N482804021406followed by a unit qualifier and the quantityPackage 82804-0214-06. 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 tablets are 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 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 patients (2 years of age and older) ( 1.1 , 1.2 ) L…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065398
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 dihydrate | Azithromycin dihydrate 250 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0431 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7350 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-3374 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0508 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-861 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4356 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-742 |