AZITHROMYCIN
- Product NDC
- 24658-708
- 11-digit product format
- 246580708
- Labeler code
- 24658
- Product ID
- 24658-708_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
- 2020-04-30
- 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 |
|---|
| 24658-708-34 | AZITHROMYCIN | 30 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 24658-708 | AZITHROMYCIN POWDER, FOR SUSPENSION [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS] | 4 | Current NDC, Legacy NDC, 1 package rows | 20231228_714f6f55-278a-4fcf-8d4e-2ad9b43623a3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 24658-708-34 | 24658070834 | 30 mL in 1 BOTTLE, PLASTIC (24658-708-34) | 30 ml | 2020-04-30 | 0000-00-00 | No | No | Current |