AZITHROMYCIN
- Product NDC
- 42806-147
- 11-digit product format
- 428060147
- Labeler code
- 42806
- Product ID
- 42806-147_8d7e7ebd-9d6a-43a9-9a4b-035cd258ff65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Epic Pharma, LLC
- Application
- ANDA207531
- Marketing category
- ANDA
- Marketing start
- 2018-04-10
- 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 | 141963, 308459 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42806-147-31 | AZITHROMYCIN | 15 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 15 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42806-147 | AZITHROMYCIN POWDER, FOR SUSPENSION [EPIC PHARMA, LLC] | 14 | Current NDC, Legacy NDC, 1 package rows | 20221230_59c4b783-4ff7-4269-969b-58a10e12b12b.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 |
|---|
| 42806-147-31 | 42806014731 | 15 mL in 1 BOTTLE, PLASTIC (42806-147-31) | 15 ml | 2018-04-10 | 0000-00-00 | No | No | Current |