Azithromycin Monohydrate
- Product NDC
- 65162-708
- 11-digit product format
- 651620708
- Labeler code
- 65162
- Product ID
- 65162-708_82138e21-e33f-497a-9c22-a7ef292af8a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Monohydrate
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA205666
- Marketing category
- ANDA
- Marketing start
- 2018-07-23
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 100 mg/5mL
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-708 | AZITHROMYCIN MONOHYDRATE POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS LLC] | 21 | Legacy NDC | 20241025_ca7aa2f0-514c-43bc-9bc2-021b4f059c5b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65162-708-83 | 65162070883 | 1 BOTTLE in 1 CARTON (65162-708-83) > 15 mL in 1 BOTTLE | 1 bottle | 2018-07-23 | 0000-00-00 | No | No | Current |