Prescription drug · ANDA
azithromycin dihydrate NDC 80425-0412
Azithromycin dihydrate 500 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0412-1 | 8042504120180425041201 | 1 BLISTER PACK in 1 CARTON (80425-0412-1) / 3 TABLET in 1 BLISTER PACKMarketed from Jul 10, 2024 |
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 dihydrate
- Generic name (nonproprietary)
- azithromycin dihydrate
- Active ingredients
- Azithromycin dihydrate — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065399
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 80425-0412_1d0e96cf-245e-cfb7-e063-6294a90a4cedSPL ID 1d0e96cf-245e-cfb7-e063-6294a90a4cedSPL set ID 1cec44fa-9597-3e58-e063-6394a90ae326RxCUI 248656, 749780UNII 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
N480425041201followed by a unit qualifier and the quantityPackage 80425-0412-01. 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 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 and cervicitis in adults ( 1.1 ) Genital ulcer disease in men ( 1.1 ) Acute otitis media in pediatric patients (6 months of age and older) ( 1.2 ) Community-acquired pneumonia in adults and pediatric patients (6 months of age and older) ( 1.1 , 1.2 ) Pharyngitis/tonsillitis in adults and pediatric patients (2 years of age and older) ( 1.1 , 1.2 ) Limitation of Use…
Excerpt only. Read the full label for complete information.
About NDC 80425-0412
- What is NDC 80425-0412?
- 80425-0412 is the product NDC for azithromycin dihydrate, Azithromycin dihydrate 500 mg/1 tablet, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- azithromycin dihydrate.
- What is the active ingredient?
- Azithromycin dihydrate.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for azithromycin dihydrate?
- 42 other product NDCs are listed under this name. See all azithromycin dihydrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other azithromycin dihydrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1607 | 67046-1607-03 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1502 | 67046-1502-03 |
| azithromycin dihydrate | Azithromycin dihydrate 600 mg/1 | TabletOral | Coupler LLC | 67046-1503 | 67046-1503-03 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8800 | 68788-8800-06 |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8773 | 68788-8773-0368788-8773-04 |
| Azithromycin Dihydrate | Azithromycin dihydrate 600 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4202 | 70518-4202-00 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Quality Care Products, LLC | 83008-081 | 83008-0081-06 |
| azithromycin dihydrate | Azithromycin dihydrate 250 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0431 | 80425-0431-01 |
| Azithromycin Dihydrate | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4160 | 70518-4160-0070518-4160-0170518-4160-02+3 more |
| Azithromycin Dihydrate | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4105 | 70518-4105-0070518-4105-0170518-4105-02 |
Other NDCs under ANDA 065399
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 | Major Pharmaceuticals | 0904-7351 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | American Health Packaging | 60687-753 |
| azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Lupin Pharmaceuticals, Inc. | 68180-862 |
| azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4367 |