Azithromycin Dihydrate
- Product NDC
- 82804-182
- 11-digit product format
- 828040182
- Labeler code
- 82804
- Product ID
- 82804-182_a8e106cb-7245-45a5-9aad-bd624b1e011d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5FD1131I7S | AZITHROMYCIN DIHYDRATE | 117772-70-0 | AZITHROMYCIN DIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-182-06 | 82804018206 | 1 BLISTER PACK in 1 CARTON (82804-182-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2025-01-20 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin Dihydrate | Proficient Rx LP | 2025-01-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |