Prescription drug · ANDA
Azithromycin NDC 60687-742
Azithromycin dihydrate 250 mg/1 · Tablet, Film coated · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-742-01 | 60687074201 | 100 BLISTER PACK in 1 CARTON (60687-742-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-742-11)Marketed from Jul 17, 2023 | |
| 60687-742-65 | 60687074265 | 50 BLISTER PACK in 1 CARTON (60687-742-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-742-11)Marketed from Apr 20, 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
- American Health Packaging
- 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 60687-742_37616a61-0547-5914-e063-6294a90a2cb0SPL ID 37616a61-0547-5914-e063-6294a90a2cb0SPL set ID 6169e56c-10fb-448d-ab0f-14e54fcf2817RxCUI 248656, 308460UNII 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
N460687074201followed by a unit qualifier and the quantityPackage 60687-0742-01. 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 (1.1…
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 | Proficient Rx LP | 82804-214 |
| 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 |