Prescription drug · ANDA
azithromycin NDC 70518-4367
Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-4367-0 | 7051843670070518436700 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4367-0)Marketed from Jun 20, 2025 | |
| 70518-4367-1 | 7051843670170518436701 | 2 POUCH in 1 BOX (70518-4367-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-4367-2)Marketed from Jun 25, 2025 | |
| 70518-4367-3 | 7051843670370518436703 | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4367-3)Marketed from Sep 26, 2025 | |
| 70518-4367-4 | 7051843670470518436704 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4367-4)Marketed from Sep 1, 2026 |
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 dihydrate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- 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 70518-4367_5a7f288b-4e9c-15e9-e063-6294a90a949bSPL ID 5a7f288b-4e9c-15e9-e063-6294a90a949bSPL set ID bf061799-cdef-40f8-b1ce-bc5eb609f8c3RxCUI 248656UNII 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
N470518436700followed by a unit qualifier and the quantityPackage 70518-4367-00. 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 70518-4367
- What is NDC 70518-4367?
- 70518-4367 is the product NDC for azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK INC.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- azithromycin.
- What is the active ingredient?
- Azithromycin dihydrate.
- Who is the labeler?
- REMEDYREPACK INC., NDC labeler code 70518. 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?
- 146 other product NDCs are listed under this name. See all azithromycin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other azithromycin 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 | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1698 | 67046-1698-03 |
| azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-726 | 64980-0726-0364980-0726-13 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-727 | 64980-0727-0364980-0727-16 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0508 | 67046-0508-03 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-129 | 11788-0129-1311788-0129-1411788-0129-15 |
| Azithromycin | Azithromycin dihydrate 100 mg/5mL | Powder, For suspensionOral | AiPing Pharmaceutical, Inc. | 11788-128 | 11788-0128-13 |
| Azithromycin | Azithromycin dihydrate 200 mg/5mL | Powder, For suspensionOral | A-S Medication Solutions | 50090-8144 | 50090-8144-00 |
| Azithromycinazithromycin monohydrate | Azithromycin monohydrate 500 mg/5mL | Injection, Powder, Lyophilized, For solutionIntravenous | Sagent Pharmaceuticals | 25021-180 | 25021-0180-10 |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4356 | 70518-4356-00 |
| Azithromycin | Azithromycin monohydrate 200 mg/5mL | Powder, For suspensionOral | PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS | 24658-707 | 24658-0707-33 |
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 dihydrate | Azithromycin dihydrate 500 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0412 |