Azithromycin Dihydrate
- Product NDC
- 82804-153
- 11-digit product format
- 828040153
- Labeler code
- 82804
- Product ID
- 82804-153_edecf20d-c681-418b-9c47-02fb32d2b3c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-153-04 | 82804015304 | 4 TABLET, FILM COATED in 1 BOTTLE (82804-153-04) | 2024-09-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin Dihydrate | Proficient Rx LP | 2024-09-01 | HUMAN PRESCRIPTION DRUG LABEL | 1 |