azithromycin monohydrate
- Product NDC
- 68180-162
- 11-digit product format
- 681800162
- Labeler code
- 68180
- Product ID
- 68180-162_e6e8dd21-bd53-43d4-80d1-61eb0ba449c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Lupin Pharmaceuticals, Inc.
- Application
- ANDA065400
- Marketing category
- ANDA
- Marketing start
- 2015-08-18
- Marketing end
- 2024-05-31
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 600 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 68180-162-06 | 68180016206 | 30 TABLET in 1 CONTAINER (68180-162-06) | 30 tablet | 2015-08-18 | 0000-00-00 | No | No | Current |