azithromycin monohydrate
- Product NDC
- 0904-6708
- 11-digit product format
- 009046708
- Labeler code
- 0904
- Product ID
- 0904-6708_977dca0c-2c51-4f72-8962-cd89e7474b57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 250 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 |
|---|
| 0904-6708-06 | 00904670806 | 5 BLISTER PACK in 1 CARTON (0904-6708-06) > 10 TABLET in 1 BLISTER PACK | 5 blister pack | 2015-08-18 | 0000-00-00 | No | No | Current |
| 0904-6708-61 | 00904670861 | 10 BLISTER PACK in 1 CARTON (0904-6708-61) > 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2015-08-18 | 0000-00-00 | No | No | Current |