Azithromycin Dihydrate
- Product NDC
- 68071-3715
- 11-digit product format
- 680713715
- Labeler code
- 68071
- Product ID
- 68071-3715_2a32433c-0956-9672-e063-6394a90a1ac3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals Inc.
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2024-02-15
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-3715-4 | Azithromycin Dihydrate | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-3715 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS INC.] | 2 | Current NDC, 1 package rows | 20241228_258dd3c5-dce9-7483-e063-6294a90a4043.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68071-3715-4 | 68071371504 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-3715-4) | 2024-10-28 | No | No | Current |