Azithromycin Dihydrate
- Product NDC
- 67046-1607
- 11-digit product format
- 670461607
- Labeler code
- 67046
- Product ID
- 67046-1607_4196de9a-0c36-7cfe-e063-6394a90a409a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2025-10-20
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5FD1131I7S | AZITHROMYCIN DIHYDRATE | 117772-70-0 | AZITHROMYCIN DIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1607-3 | 67046160703 | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1607-3) | 2025-10-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin Dihydrate | Coupler LLC | 2025-10-20 | HUMAN PRESCRIPTION DRUG LABEL | 1 |