Azithromycin
- Product NDC
- 76420-589
- 11-digit product format
- 764200589
- Labeler code
- 76420
- Product ID
- 76420-589_04472220-f8c1-1f1a-e063-6294a90a2bb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA065223
- Marketing category
- ANDA
- Marketing start
- 2006-01-06
- Substance
- AZITHROMYCIN MONOHYDRATE
- 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
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 248656, 308460, 749780, 749783 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76420-589-03 | Azithromycin | 3 in 1 BLISTER PACK | TABLET, FILM COATED | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-589 | AZITHROMYCIN TABLET, FILM COATED [ASCLEMED USA, INC.] | 3 | Current NDC, 1 package rows | 20230902_9c44af6d-8a9a-cb4c-e053-2a95a90afdac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 76420-589-03 | 76420058903 | 3 TABLET, FILM COATED in 1 BLISTER PACK (76420-589-03) | 2023-09-01 | No | No | Current |