Azithromycin Dihydrate
- Product NDC
- 76420-046
- 11-digit product format
- 764200046
- Labeler code
- 76420
- Product ID
- 76420-046_ae7775dd-3ddd-58b8-e053-2995a90ad046
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Asclemed USA, Inc.
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- 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 Dihydrate
- 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 |
|---|
| 76420-046-06 | Azithromycin Dihydrate | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76420-046 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ASCLEMED USA, INC.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20200905_b08bd8fc-20da-4623-9211-ae669452b16d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76420-046-06 | 76420004606 | 6 TABLET, FILM COATED in 1 BLISTER PACK (76420-046-06) | 2020-09-04 | 0000-00-00 | No | No | Current |