azithromycin monohydrate
- Product NDC
- 0904-6909
- 11-digit product format
- 009046909
- Labeler code
- 0904
- Product ID
- 0904-6909_977dca0c-2c51-4f72-8962-cd89e7474b57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0904-6909-04 | 00904690904 | 3 BLISTER PACK in 1 CARTON (0904-6909-04) > 10 TABLET in 1 BLISTER PACK | 3 blister pack | 2015-08-18 | 0000-00-00 | No | No | Current |