Prescription drug · ANDA
Azithromycin NDC 70518-0784
Azithromycin monohydrate 250 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-0784-1 | 70518078401 | 4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0784-1)Marketed from Dec 23, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 monohydrate — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065225
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 70518-0784_558c9eca-f91a-151a-e063-6394a90a75c0SPL ID 558c9eca-f91a-151a-e063-6394a90a75c0SPL set ID 333ffe63-aaeb-4dff-b595-1c11209189a6RxCUI 308460UNII JTE4MNN1MD
- 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
N470518078401followed by a unit qualifier and the quantityPackage 70518-0784-01. 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 065225
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 monohydrate 250 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-007 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-006 |
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/1 | Tablet, Film coatedOral | PharmPak, Inc. | 54348-857 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-007 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0219 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 50111-787 |