Prescription drug · ANDA
Azithromycin NDC 71335-1755
Azithromycin dihydrate 500 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1755-1 | 7133517550171335175501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1755-1)Marketed from Jan 30, 2025 | |
| 71335-1755-2 | 7133517550271335175502 | 5 TABLET, FILM COATED in 1 BOTTLE (71335-1755-2)Marketed from Dec 30, 2020 | |
| 71335-1755-3 | 7133517550371335175503 | 2 TABLET, FILM COATED in 1 BOTTLE (71335-1755-3)Marketed from Jan 30, 2025 | |
| 71335-1755-4 | 7133517550471335175504 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-1755-4)Marketed from Jan 30, 2025 | |
| 71335-1755-5 | 7133517550571335175505 | 4 TABLET, FILM COATED in 1 BOTTLE (71335-1755-5)Marketed from Jan 30, 2025 |
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
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210001
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 71335-1755_02fdd8ac-5daf-42bc-933e-e33c2e4cf3f0SPL ID 02fdd8ac-5daf-42bc-933e-e33c2e4cf3f0SPL set ID b5d79719-b1dc-469f-a19c-f8ba615138f0RxCUI 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
N471335175501followed by a unit qualifier and the quantityPackage 71335-1755-01. 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 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 is 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 ) Ur…
Excerpt only. Read the full label for complete information.
About NDC 71335-1755
- What is NDC 71335-1755?
- 71335-1755 is the product NDC for Azithromycin, Azithromycin dihydrate 500 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 5 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 500 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4367 | 70518-4367-0070518-4367-0170518-4367-03+1 more |
| azithromycin | Azithromycin dihydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4356 | 70518-4356-00 |
Other NDCs under ANDA 210001
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 | AvKARE | 42291-083 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2297 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-503 |
| Azithromycin | Azithromycin dihydrate 500 mg/1 | Tablet, Film coatedOral | DIRECT RX | 72189-088 |