AZITHROMYCIN
- Product NDC
- 53002-2231
- 11-digit product format
- 530022231
- Labeler code
- 53002
- Product ID
- 53002-2231_cdf43e09-9c96-4040-b33a-0145c8c14f68
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- AZITHROMYCIN
- Dosage form
- POWDER, FOR SUSPENSION
- Route
- PARENTERAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA207531
- Marketing category
- ANDA
- Marketing start
- 2018-04-10
- Marketing end
- 0000-00-00
- Substance
- AZITHROMYCIN MONOHYDRATE
- Active strength
- 200 mg/5mL
- 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 |
|---|
| 53002-2231-1 | AZITHROMYCIN | 15 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 15 | | 3 |
| 53002-2231-2 | AZITHROMYCIN | 30 mL in 1 BOTTLE, PLASTIC | POWDER, FOR SUSPENSION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-2231 | AZITHROMYCIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 2 package rows | 20230609_1f28e1b7-6bc6-4b34-9298-c0f72cc95ada.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 |
|---|
| 53002-2231-1 | 53002223101 | 15 mL in 1 BOTTLE, PLASTIC (53002-2231-1) | 15 ml | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-2231-2 | 53002223102 | 30 mL in 1 BOTTLE, PLASTIC (53002-2231-2) | 30 ml | 2020-01-01 | 0000-00-00 | No | No | Current |