Azithromycin
- Product NDC
- 62135-704
- 11-digit product format
- 621350704
- Labeler code
- 62135
- Product ID
- 62135-704_15af5062-22b6-c8b6-e063-6294a90a7df3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA065488
- Marketing category
- ANDA
- Marketing start
- 2015-05-15
- Substance
- AZITHROMYCIN MONOHYDRATE
- 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 MONOHYDRATE | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 141963, 308459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-704-51 | Azithromycin | 15 mL in 1 BOTTLE | SUSPENSION | 15 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-704 | AZITHROMYCIN SUSPENSION [CHARTWELL RX, LLC] | 1 | Current NDC, 1 package rows | 20240410_2c9de2e9-c20c-4660-a272-a22019f9fb02.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 |
|---|
| 62135-704-51 | 62135070451 | 15 mL in 1 BOTTLE (62135-704-51) | 15 ml | 2024-03-07 | No | No | Current |