Azithromycin
- Product NDC
- 50090-4458
- 11-digit product format
- 500904458
- Labeler code
- 50090
- Product ID
- 50090-4458_57c5f28a-3308-4eb6-ae6d-9e911f1f6989
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA211147
- Marketing category
- ANDA
- Marketing start
- 2018-08-06
- Substance
- AZITHROMYCIN DIHYDRATE
- 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 DIHYDRATE | 200 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 141963 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50090-4458-0 | Azithromycin | 30 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 30 | | 8 |
| 50090-4458-0 | Azithromycin | 1 in 1 CARTON | POWDER, FOR SUSPENSION | 1 | | 8 |
| 50090-4458-1 | Azithromycin | 30 in 1 BOTTLE | POWDER, FOR SUSPENSION | 30 | | 8 |
| 50090-4458-1 | Azithromycin | 24 mL in 1 CASE | POWDER, FOR SUSPENSION | 24 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-4458 | AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS] | 8 | Current NDC, Legacy NDC, 4 package rows | 20230208_22a2bdcb-3012-42fb-ac66-d1d879100940.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 |
|---|
| 50090-4458-0 | 50090445800 | 1 BOTTLE in 1 CARTON (50090-4458-0) / 30 mL in 1 BOTTLE | 1 bottle | 2019-08-06 | 0000-00-00 | No | No | Current |
| 50090-4458-1 | 50090445801 | 30 CASE in 1 BOTTLE (50090-4458-1) / 24 mL in 1 CASE | 30 case | 2019-08-06 | 0000-00-00 | No | No | Current |