Azithromycin
- Product NDC
- 59651-007
- 11-digit product format
- 596510007
- Labeler code
- 59651
- Product ID
- 59651-007_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA209201
- Marketing category
- ANDA
- Marketing start
- 2018-10-09
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 100 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 DIHYDRATE | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 141963, 308459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-007-15 | Azithromycin | 15 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 15 | | 8 |
| 59651-007-15 | Azithromycin | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-007 | AZITHROMYCIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED] | 8 | Current NDC, Legacy NDC, 2 package rows | 20220523_3c902990-b870-4725-b9fe-76b8be633e1c.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 |
|---|
| 59651-007-15 | 59651000715 | 1 BOTTLE in 1 CARTON (59651-007-15) / 15 mL in 1 BOTTLE | 1 bottle | 2018-10-09 | 0000-00-00 | No | No | Current |