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
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 |
|---|
| 53002-5228-1 | Azithromycin | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 1 |
| 53002-5228-1 | Azithromycin | 6 in 1 BLISTER PACK | TABLET, FILM COATED | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-5228 | AZITHROMYCIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20220331_5a8f7836-17ef-4944-a86f-dc162a5c8e55.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| 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 |