Azithromycin
- Product NDC
- 76420-403
- 11-digit product format
- 764200403
- Labeler code
- 76420
- Product ID
- 76420-403_37fce346-d60a-f2b1-e063-6294a90a632b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ASCLEMED USA INC.
- Application
- ANDA065225
- Marketing category
- ANDA
- Marketing start
- 2006-01-06
- Substance
- AZITHROMYCIN MONOHYDRATE
- 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
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-403-06 | Azithromycin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 76420-403-06 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-403-06 | 76420040306 | 1 BLISTER PACK in 1 CARTON (76420-403-06) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2025-06-18 | No | No | Historical |