Levofloxacin
- Product NDC
- 63323-355
- 11-digit product format
- 633230355
- Labeler code
- 63323
- Product ID
- 63323-355_d2cd980c-648b-4efd-b39d-49c8e0f8f9b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOFLOXACIN
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA200674
- Marketing category
- ANDA
- Marketing start
- 2013-06-20
- Substance
- LEVOFLOXACIN
- Active strength
- 5 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levofloxacin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LEVOFLOXACIN | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 1665497, 1665507, 1665515 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-355-50 | Levofloxacin | 50 mL in 1 BAG | INJECTION | 50 | | 6 |
| 63323-355-50 | Levofloxacin | 1 in 1 POUCH | INJECTION | 1 | | 6 |
| 63323-355-60 | Levofloxacin | 1 in 1 POUCH | INJECTION | 1 | | 6 |
| 63323-355-60 | Levofloxacin | 150 mL in 1 BAG | INJECTION | 150 | | 6 |
| 63323-355-65 | Levofloxacin | 1 in 1 POUCH | INJECTION | 1 | | 6 |
| 63323-355-65 | Levofloxacin | 100 mL in 1 BAG | INJECTION | 100 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-355 | LEVOFLOXACIN INJECTION [FRESENIUS KABI USA, LLC] | 6 | Current NDC, Legacy NDC, 6 package rows | 20240524_eb30fafa-bbb9-458f-89df-ae610fa6aa96.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 |
|---|
| 63323-355-50 | 63323035550 | 1 BAG in 1 POUCH (63323-355-50) / 50 mL in 1 BAG | 1 bag | 2013-06-20 | 0000-00-00 | No | No | Current |
| 63323-355-60 | 63323035560 | 1 BAG in 1 POUCH (63323-355-60) / 150 mL in 1 BAG | 1 bag | 2013-06-20 | 0000-00-00 | No | No | Current |
| 63323-355-65 | 63323035565 | 1 BAG in 1 POUCH (63323-355-65) / 100 mL in 1 BAG | 1 bag | 2013-06-20 | 0000-00-00 | No | No | Current |