Azithromycin Dihydrate
- Product NDC
- 67296-1942
- 11-digit product format
- 672961942
- Labeler code
- 67296
- Product ID
- 67296-1942_46e925ef-1c7d-37d0-e063-6394a90a44f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Redpharm Drug
- Application
- ANDA208249
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 |
|---|
| 67296-1942-2 | Azithromycin Dihydrate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 67296-1942-2 | Azithromycin Dihydrate | 2 in 1 BOX | TABLET, FILM COATED | 2 | | 5 |
| 67296-1942-3 | Azithromycin Dihydrate | 3 in 1 BOX | TABLET, FILM COATED | 3 | | 5 |
| 67296-1942-3 | Azithromycin Dihydrate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 67296-1942-5 | Azithromycin Dihydrate | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
| 67296-1942-5 | Azithromycin Dihydrate | 5 in 1 BOX | TABLET, FILM COATED | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67296-1942 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [REDPHARM DRUG] | 3 | Current NDC, 6 package rows | 20250309_2fd1f4b5-6c32-3075-e063-6294a90a0d4b.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 |
|---|
| 67296-1942-2 | 67296194202 | 2 CARTON in 1 BOX (67296-1942-2) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK | 2 carton | 2024-02-15 | No | No | Historical |
| 67296-1942-3 | 67296194203 | 3 CARTON in 1 BOX (67296-1942-3) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK | 3 carton | 2024-02-15 | No | No | Historical |
| 67296-1942-5 | 67296194205 | 5 CARTON in 1 BOX (67296-1942-5) / 1 BLISTER PACK in 1 CARTON / 3 TABLET, FILM COATED in 1 BLISTER PACK | 5 carton | 2024-02-15 | No | No | Historical |