Prescription drug · ANDA
Azithromycin (Azithromycin monohydrate) NDC 54348-857
Azithromycin monohydrate 500 mg/1 · Tablet, Film coated · Oral · PharmPak, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54348-857-00 | 5434808570054348085700 | 1 BOTTLE in 1 BOX (54348-857-00) / 1 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019 | |
| 54348-857-01 | 5434808570154348085701 | 1 BOTTLE in 1 BOX (54348-857-01) / 1 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019 | |
| 54348-857-02 | 5434808570254348085702 | 1 BOTTLE in 1 BOX (54348-857-02) / 2 TABLET, FILM COATED in 1 BOTTLEMarketed from Jul 10, 2019 |
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 monohydrate
- Active ingredients
- Azithromycin monohydrate — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- PharmPak, Inc.NDC labeler code 54348
- 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 54348-857_eb018961-75d1-2d69-e053-2995a90a38beSPL ID eb018961-75d1-2d69-e053-2995a90a38beSPL set ID ba57ff26-cd02-4f57-ac92-b613d245a4eaRxCUI 248656UNII 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
N454348085700followed by a unit qualifier and the quantityPackage 54348-0857-00. 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 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.
About NDC 54348-857
- What is NDC 54348-857?
- 54348-857 is the product NDC for Azithromycin (azithromycin monohydrate), Azithromycin monohydrate 500 mg/1 tablet, film coated, listed with the FDA by PharmPak, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azithromycin (Azithromycin monohydrate).
- What is the active ingredient?
- Azithromycin monohydrate.
- Who is the labeler?
- PharmPak, Inc., NDC labeler code 54348. 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 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 | Teva Pharmaceuticals USA, Inc. | 50111-787 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-007 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0784 |
| Azithromycin | Azithromycin monohydrate 250 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-006 |
| 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 | Sportpharm LLC | 85766-007 |