Prescription drug · ANDA
azithromycin NDC 68180-863
Azithromycin dihydrate 600 mg/1 · Tablet, Film coated · Oral · Lupin Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68180-863-06 | 68180086306 | 30 TABLET, FILM COATED in 1 CONTAINER (68180-863-06)Marketed from Nov 17, 2022 |
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
- Active ingredients
- Azithromycin dihydrate — 600 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lupin Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 065400
- Marketing start
- Listing expires
- Other FDA classes
- Macrolides (Chemical structure)
- Identifiers
- Product ID 68180-863_f59c5ade-1749-4e5e-8891-34473bef17c2SPL ID f59c5ade-1749-4e5e-8891-34473bef17c2SPL set ID c9990a1d-5238-403e-9221-72a9314d7b5eRxCUI 204844UNII 5FD1131I7SUPC 0368180863069
- 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
N468180086306followed by a unit qualifier and the quantityPackage 68180-0863-06. 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 tablet is a macrolide antibacterial indicated for the treatment of adult patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: Mycobacterial Infections ( 1.2 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets and other antibacterial drugs, azithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.3 ) 1.2 Mycobacterial Infections Azithromycin tablets are indicated for the treatment of adult patients with mild to moderate infections caused …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 065400
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 dihydrate | Azithromycin dihydrate 600 mg/1 | TabletOral | Coupler LLC | 67046-1503 |