Prescription drug · ANDA
Azithromycin (Azithromycin dihydrate) NDC 70436-019
Azithromycin dihydrate 500 mg/5mL · Injection, Powder, Lyophilized, For solution · Intravenous · Slate Run Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70436-019-82 | 7043600198270436001982 | 10 VIAL in 1 BOX (70436-019-82) / 5 mL in 1 VIALMarketed from Dec 19, 2018 |
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 dihydrate
- Active ingredients
- Azithromycin dihydrate — 500 mg/5mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Slate Run PharmaceuticalsNDC labeler code 70436
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203412
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 70436-019_ebe5ec1e-9891-ae48-e053-2a95a90afff6SPL ID ebe5ec1e-9891-ae48-e053-2a95a90afff6SPL set ID 8acce3c1-f4be-4968-a71f-3ffd9fbaa4a4RxCUI 1668238UNII 5FD1131I7SUPC 0370436019823
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N470436001982followed by a unit qualifier and the quantityPackage 70436-0019-82. 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 for Injection is a macrolide antibacterial drug indicated for the treatment of patients with infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Azithromycin for Injection is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria: Community-acquired pneumonia in adults ( 1.1 ) Pelvic inflammatory disease ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Azithromycin for Injection and other antibacterial drugs, Azithromycin for Injection should be used only to treat or prevent infections that are proven or strongly suspect…
Excerpt only. Read the full label for complete information.
About NDC 70436-019
- What is NDC 70436-019?
- 70436-019 is the product NDC for Azithromycin (azithromycin dihydrate), Azithromycin dihydrate 500 mg/5mL injection, powder, lyophilized, for solution, listed with the FDA by Slate Run Pharmaceuticals. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Azithromycin (Azithromycin Dihydrate).
- What is the active ingredient?
- Azithromycin dihydrate.
- Who is the labeler?
- Slate Run Pharmaceuticals, NDC labeler code 70436. 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 |