azithromycin monohydrate
- Product NDC
- 68071-4214
- 11-digit product format
- 680714214
- Labeler code
- 68071
- Product ID
- 68071-4214_620fa9c8-fd79-7a96-e053-2991aa0a7c34
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record