Azithromycin
- Product NDC
- 76420-589
- 11-digit product format
- 764200589
- Labeler code
- 76420
- Product ID
- 76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA065223
- Marketing category
- ANDA
- Marketing start
- 2006-01-06
- Substance
- AZITHROMYCIN MONOHYDRATE
- 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 |
|---|
| JTE4MNN1MD | AZITHROMYCIN MONOHYDRATE | 121470-24-4 | AZITHROMYCIN MONOHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-589-03 | 76420058903 | 3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03) | 2023-09-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-09-01 | HUMAN PRESCRIPTION DRUG LABEL | 3 |