Azithromycin
- Product NDC
- 85766-008
- 11-digit product format
- 857660008
- Labeler code
- 85766
- Product ID
- 85766-008_49eeafc2-f6d5-2cfd-e063-6394a90a7af6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sportpharm LLC
- Application
- ANDA065211
- Marketing category
- ANDA
- Marketing start
- 2005-11-14
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 308460, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 85766-008-06 | Azithromycin | 6 in 1 CARTON | TABLET, FILM COATED | 6 | | 3 |
| 85766-008-06 | Azithromycin | 1 in 1 DOSE PACK | TABLET, FILM COATED | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 85766-008-06 | 85766000806 | 6 DOSE PACK in 1 CARTON (85766-008-06) / 1 TABLET, FILM COATED in 1 DOSE PACK | 6 dose pack | 2025-06-18 | No | No | Current |