Levofloxacin
- Product NDC
- 59115-096
- 11-digit product format
- 591150096
- Labeler code
- 59115
- Product ID
- 59115-096_9efe5654-c187-4c9a-a702-2317f5600b6d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hikma Pharmaceutical
- Application
- ANDA078767
- Marketing category
- ANDA
- Marketing start
- 2011-06-21
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 500 mg/1
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 59115-096-50 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 59115-096-55 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 59115-096-50 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 59115-096-55 | 9bebd1f3094a… | 5416666fcb17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 59115-096-50 | 110d247fa046… | a55b01930146… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 59115-096-55 | 110d247fa046… | a55b01930146… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59115-096-50 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c368-8e05-e053-dbdaa90a074a | 1316ceed-a16e-40e4-99d6-58987db88bd3 |
| 59115-096-55 | 2019-10-29 | C162847 | 48780-1 | 960f7f55-c368-8e05-e053-dbdaa90a074a | 1316ceed-a16e-40e4-99d6-58987db88bd3 |