Azithromycin Dihydrate
- Product NDC
- 80425-0220
- 11-digit product format
- 804250220
- Labeler code
- 80425
- Product ID
- 80425-0220_2a9ae6d7-0498-3bd5-e063-6394a90a651e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2023-01-09
- Substance
- AZITHROMYCIN DIHYDRATE
- 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 Dihydrate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN DIHYDRATE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5FD1131I7S |
| Rxcui | 248656, 749780 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0220-1 | Azithromycin Dihydrate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 3 |
| 80425-0220-1 | Azithromycin Dihydrate | 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 |
|---|
| 80425-0220 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250102_f1755cf3-bf7f-be40-e053-2a95a90a8536.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 |
|---|
| 80425-0220-1 | 80425022001 | 1 BLISTER PACK in 1 CARTON (80425-0220-1) / 3 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-01-09 | 0000-00-00 | No | No | Current |