Azithromycin
- Product NDC
- 53002-5228
- 11-digit product format
- 530025228
- Labeler code
- 53002
- Product ID
- 53002-5228_701e185b-b2eb-4b1d-a4da-26440f174382
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA207370
- Marketing category
- ANDA
- Marketing start
- 2018-07-05
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC], Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 5FD1131I7S | AZITHROMYCIN DIHYDRATE | 117772-70-0 | AZITHROMYCIN DIHYDRATE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-5228-1 | 53002522801 | 1 BLISTER PACK in 1 CARTON (53002-5228-1) > 6 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2022-05-01 | 0000-00-00 | No | No | Current |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Azithromycin | RPK Pharmaceuticals, Inc. | 2022-03-30 | Human Prescription Drug Label | 1 |