AZITHROMYCIN
- Product NDC
- 72189-314
- 11-digit product format
- 721890314
- Labeler code
- 72189
- Product ID
- 72189-314_2c3cfbf7-a5af-5075-e063-6294a90a04e5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- DirectRx
- Application
- ANDA207531
- Marketing category
- ANDA
- Marketing start
- 2022-01-12
- 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 |
|---|
| 72189-314-22 | AZITHROMYCIN | 22.5 mL in 1 BOTTLE | POWDER, FOR SUSPENSION | 22.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72189-314 | AZITHROMYCIN POWDER, FOR SUSPENSION [DIRECTRX] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250122_d564d91e-3039-c120-e053-2995a90ae6db.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 |
|---|
| 72189-314-22 | 72189031422 | 22.5 mL in 1 BOTTLE (72189-314-22) | 22.5 ml | 2022-01-12 | 0000-00-00 | No | No | Current |