Azithromycin
- Product NDC
- 76420-213
- 11-digit product format
- 764200213
- Labeler code
- 76420
- Product ID
- 76420-213_23b371e7-b120-3dc4-e063-6294a90a585d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- 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
- 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 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 |
|---|
| 76420-213-06 | Azithromycin | 6 in 1 CARTON | TABLET, FILM COATED | 6 | | 2 |
| 76420-213-06 | Azithromycin | 1 in 1 DOSE PACK | TABLET, FILM COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-213 | AZITHROMYCIN TABLET, FILM COATED [ASCLEMED USA, INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20241204_22a4d2b3-daea-4d96-891f-4b9823629456.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-213-06 | 76420021306 | 6 DOSE PACK in 1 CARTON (76420-213-06) / 1 TABLET, FILM COATED in 1 DOSE PACK | 6 dose pack | 2022-03-08 | 0000-00-00 | No | No | Current |