Azithromycin
- Product NDC
- 63323-398
- 11-digit product format
- 633230398
- Labeler code
- 63323
- Product ID
- 63323-398_2143a7d1-6575-4d24-8ef4-001ecf2671e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN MONOHYDRATE
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA065179
- Marketing category
- ANDA
- Marketing start
- 2006-03-20
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 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 | 500 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 1668238 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-398-01 | Azithromycin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 8 |
| 63323-398-10 | Azithromycin | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 8 |
| 63323-398-14 | Azithromycin | 10 in 1 TRAY | INJECTION, POWDER, LYOPHILIZED, | 10 | | 4 |
| 63323-398-41 | Azithromycin | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-398 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241018_b69917c0-95d5-4b29-b0e3-07054a4fd79f.zip |
| 63323-398 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241018_9ad099d5-5c57-4855-98a4-e03fb4629dbf.zip |
| 63323-398 | AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC] | 3 | Current NDC, Legacy NDC | 20241018_62f6f327-3fef-49f0-ae90-078356d002b5.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 |
|---|
| 63323-398-01 | 63323039801 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |
| 63323-398-10 | 63323039810 | 10 VIAL in 1 TRAY (63323-398-10) / 5 mL in 1 VIAL (63323-398-01) | 10 vial | 2006-03-20 | 0000-00-00 | No | No | Current |
| 63323-398-12 | 63323039812 | 10 VIAL in 1 TRAY (63323-398-12) > 5 mL in 1 VIAL | 10 vial | 2006-03-20 | 0000-00-00 | No | No | Current |
| 63323-398-14 | 63323039814 | 10 VIAL in 1 TRAY (63323-398-14) / 5 mL in 1 VIAL (63323-398-41) | 10 vial | 2006-03-20 | 0000-00-00 | No | No | Current |
| 63323-398-41 | 63323039841 | 5 mL in 1 VIAL | 5 ml | | | | | Historical |