azithromycin dihydrate
- Product NDC
- 80425-0431
- 11-digit product format
- 804250431
- Labeler code
- 80425
- Product ID
- 80425-0431_20ae1090-cc58-39fd-e063-6294a90adfab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin dihydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA065398
- Marketing category
- ANDA
- Marketing start
- 2024-08-27
- 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 |
|---|
| 80425-0431-1 | azithromycin dihydrate | 6 in 1 BLISTER PACK | TABLET | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0431 | AZITHROMYCIN DIHYDRATE TABLET [ADVANCED RX OF TENNESSEE, LLC] | 1 | Current NDC, 1 package rows | 20240829_20ae108a-00c5-a984-e063-6394a90aaaae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0431-1 | 80425043101 | 6 TABLET in 1 BLISTER PACK (80425-0431-1) | 6 tablet | 2024-08-27 | No | No | Historical |