Levofloxacin
- Product NDC
- 53002-1391
- 11-digit product format
- 530021391
- Labeler code
- 53002
- Product ID
- 53002-1391_32095c58-82a6-489b-a33e-e84a199147af
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA200839
- Marketing category
- ANDA
- Marketing start
- 2012-03-22
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 250 mg/1
- 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 |
|---|
| 53002-1391-1 | Levofloxacin | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 1 |
| 53002-1391-3 | Levofloxacin | 3 in 1 BOTTLE | TABLET, FILM COATED | 3 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1391 | LEVOFLOXACIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 1 | Legacy NDC, 2 package rows | 20201222_75480aa3-0703-40bb-8fdf-12bc0d46d973.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 |
|---|
| 53002-1391-1 | 53002139101 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-1391-1) | 2020-01-01 | 0000-00-00 | No | No | Current |
| 53002-1391-3 | 53002139103 | 3 TABLET, FILM COATED in 1 BOTTLE (53002-1391-3) | 2020-01-01 | 0000-00-00 | No | No | Current |