azithromycin monohydrate
- Product NDC
- 53217-403
- 11-digit product format
- 532170403
- Labeler code
- 53217
- Product ID
- 53217-403_aa0c79b4-21c9-4628-87cb-4e47fbdc567d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin monohydrate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA065399
- Marketing category
- ANDA
- Marketing start
- 2018-08-10
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53217-403-01 | azithromycin monohydrate | 3 in 1 BLISTER PACK | TABLET | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53217-403 | AZITHROMYCIN MONOHYDRATE TABLET [AIDAREX PHARMACEUTICALS LLC] | 1 | Legacy NDC, 1 package rows | 20180825_f07ac620-b9a3-4aa4-92cc-dde90e52670d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53217-403-01 | 53217040301 | 3 in 1 BLISTER PACK | Historical |