Azithromycin
- Product NDC
- 71205-503
- 11-digit product format
- 712050503
- Labeler code
- 71205
- Product ID
- 71205-503_31df881c-4b9b-4717-8f76-98b6ca8be644
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA210001
- Marketing category
- ANDA
- Marketing start
- 2019-03-12
- 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-503-03 | 71205050303 | 1 BLISTER PACK in 1 BAG (71205-503-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2021-02-26 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin | Proficient Rx LP | 2022-11-01 | HUMAN PRESCRIPTION DRUG LABEL | 2 |