azithromycin monohydrate
- Product NDC
- 48792-7869
- 11-digit product format
- 487927869
- Labeler code
- 48792
- Product ID
- 48792-7869_7d767e67-b16a-7276-e053-2991aa0a0609
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sunshine Lake Pharma Co., Ltd.
- Application
- ANDA209045
- Marketing category
- ANDA
- Marketing start
- 2018-12-20
- 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
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 48792-7869-1 | 48792786901 | 30 TABLET, FILM COATED in 1 BOTTLE (48792-7869-1) | 2018-12-20 | 0000-00-00 | No | No | Current |