azithromycin monohydrate
- Product NDC
- 68071-3187
- 11-digit product format
- 680713187
- Labeler code
- 68071
- Product ID
- 68071-3187_55efe92b-129b-0a1e-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record