Levofloxacin
- Product NDC
- 53002-1350
- 11-digit product format
- 530021350
- Labeler code
- 53002
- Product ID
- 53002-1350_8b41f374-2fe3-455f-bd00-8c648336b7e4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- RPK Pharmaceuticals, Inc.
- Application
- ANDA202801
- Marketing category
- ANDA
- Marketing start
- 2015-01-09
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 500 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#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 53002-1350-1 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-5 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-7 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-9 | 2025-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-1 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-5 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-7 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-9 | 2023-06-08 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-1 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-5 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-7 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-9 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-1 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-5 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-7 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-9 | 2020-12-15 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-5 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-7 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
| 53002-1350-9 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-433c-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS safely and effectively. See full prescribing information for LEVOFLOXACIN TABLETS. LEVOFLOXACIN tablets, for oral use Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53002-1350-1 | Levofloxacin | 10 in 1 BOTTLE | TABLET, FILM COATED | 10 | | 5 |
| 53002-1350-5 | Levofloxacin | 5 in 1 BOTTLE | TABLET, FILM COATED | 5 | | 5 |
| 53002-1350-7 | Levofloxacin | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 5 |
| 53002-1350-9 | Levofloxacin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53002-1350 | LEVOFLOXACIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.] | 5 | Legacy NDC, 4 package rows | 20230609_daa51cd2-b877-488a-b4a1-3b06487627c6.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 |
|---|
| 53002-1350-1 | 53002135001 | 10 TABLET, FILM COATED in 1 BOTTLE (53002-1350-1) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1350-5 | 53002135005 | 5 TABLET, FILM COATED in 1 BOTTLE (53002-1350-5) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1350-7 | 53002135007 | 7 TABLET, FILM COATED in 1 BOTTLE (53002-1350-7) | 2017-09-01 | 0000-00-00 | No | No | Current |
| 53002-1350-9 | 53002135009 | 14 TABLET, FILM COATED in 1 BOTTLE (53002-1350-9) | 2017-09-01 | 0000-00-00 | No | No | Current |