Azithromycin
- Product NDC
- 53002-0472
- 11-digit product format
- 530020472
- Labeler code
- 53002
- Product ID
- 53002-0472_6ab1eca7-0c22-467e-b685-7020ac6489fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065405
- Marketing category
- ANDA
- Marketing start
- 2008-02-11
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN DIHYDRATE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Macrolide Antimicrobial [EPC],Macrolides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 |
|---|
| 53002-0472-1 | Azithromycin | 3 in 1 DOSE PACK | TABLET, FILM COATED | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-0472 | AZITHROMYCIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 1 package rows | 20210106_1846ad3c-26ed-4c6f-8dae-a0f3502df3e0.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53002-0472-1 | 53002047201 | 3 TABLET, FILM COATED in 1 DOSE PACK (53002-0472-1) | 2019-01-01 | 0000-00-00 | No | No | Current |