azithromycin
- Product NDC
- 0904-7350
- 11-digit product format
- 009047350
- Labeler code
- 0904
- Product ID
- 0904-7350_7cae275e-abb8-4fad-af20-fa3fdbf095e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2023-05-01
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0904-7350-06 | 00904735006 | 50 BLISTER PACK in 1 CARTON (0904-7350-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 50 blister pack | 2023-05-01 | No | No | Historical |
| 0904-7350-61 | 00904735061 | 100 BLISTER PACK in 1 CARTON (0904-7350-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK | 100 blister pack | 2023-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| azithromycin | Cardinal Health 107, LLC | 2026-04-10 | HUMAN PRESCRIPTION DRUG LABEL | 3 |
| azithromycin | Major Pharmaceuticals | 2025-07-03 | HUMAN PRESCRIPTION DRUG LABEL | 5 |