Azithromycin Dihydrate
- Product NDC
- 80425-0218
- 11-digit product format
- 804250218
- Labeler code
- 80425
- Product ID
- 80425-0218_2a9aa671-d0a1-2254-e063-6294a90a9f79
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2023-01-09
- 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 |
|---|
| 80425-0218-1 | Azithromycin Dihydrate | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 3 |
| 80425-0218-1 | Azithromycin Dihydrate | 1 in 1 BOX | TABLET, FILM COATED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0218 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250102_f1752913-85ac-01fa-e053-2995a90a2bd8.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 |
|---|
| 80425-0218-1 | 80425021801 | 1 BLISTER PACK in 1 BOX (80425-0218-1) / 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2023-01-09 | 0000-00-00 | No | No | Current |