AZITHROMYCIN
- Product NDC
- 68071-3897
- 11-digit product format
- 680713897
- Labeler code
- 68071
- Product ID
- 68071-3897_3f7c742b-a360-bef8-e063-6294a90a93ed
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA207531
- Marketing category
- ANDA
- Marketing start
- 2018-04-10
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 200 mg/5mL
- 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 |
|---|
| 68071-3897-2 | 68071389702 | 22.5 mL in 1 BOTTLE, PLASTIC (68071-3897-2) | 22.5 ml | 2025-09-23 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| AZITHROMYCIN | NuCare Pharmaceuticals, Inc. | 2025-09-23 | HUMAN PRESCRIPTION DRUG LABEL | 1 |