Azithromycin Dihydrate
- Product NDC
- 53002-2221
- 11-digit product format
- 530022221
- Labeler code
- 53002
- Product ID
- 53002-2221_0eeb437e-d05a-489d-9b82-6fd264b53eee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- azithromycin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA065509
- Marketing category
- ANDA
- Marketing start
- 2011-07-18
- 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
- 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 |
|---|
| 53002-2221-2 | Azithromycin Dihydrate | 2 in 1 BOTTLE | TABLET, FILM COATED | 2 | | 1 |
| 53002-2221-5 | Azithromycin Dihydrate | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 1 |
| 53002-2221-6 | Azithromycin Dihydrate | 6 in 1 BOTTLE | TABLET, FILM COATED | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2221 | AZITHROMYCIN DIHYDRATE (AZITHROMYCIN) TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 3 package rows | 20180110_7e228ad6-2c24-4994-a0d0-040f59eaa4d2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 53002-2221-2 | 53002222102 | 2 in 1 BOTTLE | Historical |
| 53002-2221-5 | 53002222105 | 5 in 1 BOTTLE | Historical |
| 53002-2221-6 | 53002222106 | 6 in 1 BOTTLE | Historical |