Azithromycin
- Product NDC
- 68071-4779
- 11-digit product format
- 680714779
- Labeler code
- 68071
- Product ID
- 68071-4779_1adc1010-cc6d-31f2-e063-6394a90a64c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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 |
|---|
| 68071-4779-3 | Azithromycin | 30 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4779 | AZITHROMYCIN POWDER, FOR SUSPENSION [NUCARE PHARMACEUTICALS,INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20240616_826f9c07-8eb9-a128-e053-2991aa0ad654.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 |
|---|
| 68071-4779-3 | 68071477903 | 30 mL in 1 BOTTLE (68071-4779-3) | 30 ml | 2019-02-21 | 0000-00-00 | No | No | Current |