Prescription drug · ANDA
Azithromycin NDC 76420-649
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-649-06 | 76420064906 | 6 TABLET, FILM COATED in 1 BOTTLE (76420-649-06)Marketed from Dec 31, 2023 |
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
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210000
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 76420-649_0dc7bda4-7a99-9041-e063-6294a90a5157SPL ID 0dc7bda4-7a99-9041-e063-6294a90a5157SPL set ID b77b347d-d357-4bdf-b985-49d9a1dd634cRxCUI 308460, 749783UNII 5FD1131I7S
- 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
N476420064906followed by a unit qualifier and the quantityPackage 76420-0649-06. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 210000
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 | DIRECT RX | 72189-093 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-082 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6436 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2266 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-424 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Bionpharma Inc. | 69452-171 |
| Azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Doc Rx | 69306-250 |