AZITHROMYCIN
- Product NDC
- 24658-707
- 11-digit product format
- 246580707
- Labeler code
- 24658
- Product ID
- 24658-707_7ee7f155-19fe-42cd-ad83-a3a2fb6f34f9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
- Application
- ANDA207531
- Marketing category
- ANDA
- Marketing start
- 2025-05-30
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AZITHROMYCIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 141963 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24658-707-33 | AZITHROMYCIN | 22.5 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 22.5 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 24658-707-33 | 24658070733 | 22.5 mL in 1 BOTTLE, PLASTIC (24658-707-33) | 22.5 ml | 2025-05-30 | No | No | Current |