Azithromycin monohydrate
- Product NDC
- 70095-025
- 11-digit product format
- 700950025
- Labeler code
- 70095
- Product ID
- 70095-025_dd9fbcb9-f8e5-417f-98b0-6ba9939982c1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin monohydrate
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sun Pharmaceutical Industries Limited
- Application
- ANDA065501
- Marketing category
- ANDA
- Marketing start
- 2023-03-27
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 mg/10mL
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70095-025-02 | 70095002502 | 10 VIAL in 1 CARTON (70095-025-02) / 10 mL in 1 VIAL (70095-025-01) | 10 vial | 2023-03-27 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin monohydrate | Sun Pharmaceutical Industries Limited | Gland Pharma Limited | 2023-06-20 | Human Prescription Drug Label | 2 |