azithromycin monohydrate
- Product NDC
- 68788-7654
- 11-digit product format
- 687887654
- Labeler code
- 68788
- Product ID
- 68788-7654_6359e9a8-1bd6-42f1-b8ba-4f4aa1bb3be1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2020-02-28
- 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 |
|---|
| 68788-7654-6 | 68788765406 | 6 TABLET in 1 BLISTER PACK (68788-7654-6) | 6 tablet | 2020-02-28 | 0000-00-00 | No | No | Current |