Azithromycin
- Product NDC
- 76420-649
- 11-digit product format
- 764200649
- Labeler code
- 76420
- Product ID
- 76420-649_0dc7bda4-7a99-9041-e063-6294a90a5157
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA210000
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-649-06 | 76420064906 | 6 TABLET, FILM COATED in 1 BOTTLE (76420-649-06) | 2023-12-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin | Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM | 2023-12-30 | HUMAN PRESCRIPTION DRUG LABEL | 1 |