AZITHROMYCIN
- Product NDC
- 50090-6226
- 11-digit product format
- 500906226
- Labeler code
- 50090
- Product ID
- 50090-6226_c0981152-20d0-449e-a639-28342c965a36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- 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
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 |
|---|
| 50090-6226-0 | AZITHROMYCIN | 22.5 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 22.5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-6226 | AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS] | 5 | Current NDC, 1 package rows | 20230414_76093152-e2d7-4fe1-8568-1f0fec1747c2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50090-6226-0 | 50090622600 | 22.5 mL in 1 BOTTLE, PLASTIC (50090-6226-0) | 22.5 ml | 2022-11-14 | No | No | Current |