Azithromycin
- Product NDC
- 42291-044
- 11-digit product format
- 422910044
- Labeler code
- 42291
- Product ID
- 42291-044_484c1370-43ba-a9a6-e063-6294a90ab468
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA065218
- Marketing category
- ANDA
- Marketing start
- 2024-04-24
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 600 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Azithromycin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| AZITHROMYCIN MONOHYDRATE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JTE4MNN1MD |
| Rxcui | 204844 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-044-30 | Azithromycin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-044 | AZITHROMYCIN TABLET, FILM COATED [AVKARE] | 1 | Current NDC, 1 package rows | 20240426_16da30a2-d11c-7e8c-e063-6294a90a62e3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 42291-044-30 | 42291004430 | 30 TABLET, FILM COATED in 1 BOTTLE (42291-044-30) | 2024-04-24 | No | No | Current |