Prescription drug · ANDA
azithromycin NDC 0527-2370
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0527-2370-20 | 00527237020 | 6 TABLET, FILM COATED in 1 BLISTER PACK (0527-2370-20)Marketed from Oct 22, 2024 | |
| 0527-2370-32 | 00527237032 | 30 TABLET, FILM COATED in 1 BOTTLE (0527-2370-32)Marketed from Jul 4, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Lannett Company, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209045
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 0527-2370_371e26cf-af95-77d5-e063-6294a90a34b5SPL ID 371e26cf-af95-77d5-e063-6294a90a34b5SPL set ID a2b0c06b-e93d-f5aa-e053-2995a90ac9aaRxCUI 248656, 308460, 749780, 749783UNII 5FD1131I7SUPC 0305272370203
- 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
N400527237020followed by a unit qualifier and the quantityPackage 00527-2370-20. 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 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 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 structure infections in adults ( 1.1 ) Urethritis…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209045
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 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-727 |