Prescription drug · ANDA
Azithromycin NDC 62332-252
Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-252-03 | 62332025203 | 3 BLISTER PACK in 1 CARTON (62332-252-03) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 29, 2020 | |
| 62332-252-09 | 62332025209 | 3 BLISTER PACK in 1 CARTON (62332-252-09) / 3 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 29, 2020 | |
| 62332-252-30 | 62332025230 | 30 TABLET, FILM COATED in 1 BOTTLE (62332-252-30)Marketed from Jan 29, 2020 |
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 — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211792
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 62332-252_a6585638-3730-443c-895f-b54980943d21SPL ID a6585638-3730-443c-895f-b54980943d21SPL set ID 45410338-6bff-476b-b8e1-6c6238205a99RxCUI 248656, 749780UNII 5FD1131I7SUPC 0362332252305
- 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
N462332025203followed by a unit qualifier and the quantityPackage 62332-0252-03. 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 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 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 211792
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 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3254 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Alembic Pharmaceuticals Limited | 46708-058 |