Azithromycin Dihydrate
- Product NDC
- 53002-3224
- 11-digit product format
- 530023224
- Labeler code
- 53002
- Product ID
- 53002-3224_74922948-e205-4085-bfa5-1ffbe5f2b9f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Azithromycin Dihydrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA208250
- Marketing category
- ANDA
- Marketing start
- 2019-07-01
- 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 |
|---|
| 53002-3224-1 | Azithromycin Dihydrate | 4 in 1 BOTTLE | TABLET, FILM COATED | 4 | | 1 |
| 53002-3224-3 | Azithromycin Dihydrate | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-3224 | AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20220331_99eb5289-dc06-4594-bdd7-83493d469f82.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 |
|---|
| 53002-3224-1 | 53002322401 | 4 TABLET, FILM COATED in 1 BOTTLE (53002-3224-1) | 2021-01-01 | 0000-00-00 | No | No | Current |
| 53002-3224-3 | 53002322403 | 30 TABLET, FILM COATED in 1 BOTTLE (53002-3224-3) | 2021-01-01 | 0000-00-00 | No | No | Current |