Azithromycin
- Product NDC
- 68788-8675
- 11-digit product format
- 687888675
- Labeler code
- 68788
- Product ID
- 68788-8675_b24a545d-b889-455f-be44-e9d2b9215583
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA065246
- Marketing category
- ANDA
- Marketing start
- 2024-05-23
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 308459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-8675-1 | Azithromycin | 15 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-8675 | AZITHROMYCIN POWDER, FOR SUSPENSION [PREFERRED PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20250207_ac327054-21ab-401c-a27a-48259db18f89.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 |
|---|
| 68788-8675-1 | 68788867501 | 15 mL in 1 BOTTLE (68788-8675-1) | 15 ml | 2024-05-23 | No | No | Historical |