Levofloxacin
- Product NDC
- 33261-876
- 11-digit product format
- 332610876
- Labeler code
- 33261
- Product ID
- 33261-876_5de98130-babf-405b-994a-d117eef9ef57
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA090367
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 750 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| addb5519-f7ae-4d4e-b9ca-f782a1597fd3 | Product name | 2 | 20210610 |
| fb758c6a-fdee-40a8-99c2-46f79c3ff90c | Product name | 4 | 20200807 |
| 1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d | Product name | 1 | 20190618 |
| aea4a616-4dfe-45f6-94bb-8b9063056ceb | Product name | 6 | 20190611 |
| 2246ce8e-a477-4dc3-b6d6-fe9973c18ed1 | Product name | 1 | 20180821 |
| 5a6c788d-375b-4565-a8ae-67c179a30c93 | Product name | 1 | 20180212 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 33261-876-10 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-75df-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996 |
| 33261-876-30 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-75df-f424-e053-dadaa90a57ce | These highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets Initial U.S. Approval: 1996 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 33261-876-10 | Levofloxacin | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | 1 | |
| 33261-876-30 | Levofloxacin | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 199884 | levoFLOXacin 250 MG Oral Tablet | PSN | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
| 199885 | levoFLOXacin 500 MG Oral Tablet | PSN | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
| 311296 | levoFLOXacin 750 MG Oral Tablet | PSN | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
| 199884 | levofloxacin 250 MG Oral Tablet | SCD | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
| 199885 | levofloxacin 500 MG Oral Tablet | SCD | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
| 311296 | levofloxacin 750 MG Oral Tablet | SCD | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
| 199884 | levofloxacin (as levofloxacin hemihydrate) 250 MG Oral Tablet | SY | 56e8ffbe-59a6-4f6a-b2f9-43b4e339ef6b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 33261-876-10 | 33261087610 | 10 in 1 BOTTLE, PLASTIC | Historical |
| 33261-876-30 | 33261087630 | 30 in 1 BOTTLE, PLASTIC | Historical |