Azithromycin Dihydrate
- Product NDC
- 71335-2581
- 11-digit product format
- 713352581
- Labeler code
- 71335
- Product ID
- 71335-2581_d3a94453-1704-4bb6-afd2-d678de7475a0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin Dihydrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 248656 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71335-2581-1 | 71335258101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2581-1) | 2025-03-13 | No | No | Historical |
| 71335-2581-2 | 71335258102 | 5 TABLET, FILM COATED in 1 BOTTLE (71335-2581-2) | 2025-03-13 | No | No | Historical |
| 71335-2581-3 | 71335258103 | 2 TABLET, FILM COATED in 1 BOTTLE (71335-2581-3) | 2025-03-13 | No | No | Historical |
| 71335-2581-4 | 71335258104 | 6 TABLET, FILM COATED in 1 BOTTLE (71335-2581-4) | 2025-03-13 | No | No | Historical |