Levofloxacin
- Product NDC
- 54288-140
- 11-digit product format
- 542880140
- Labeler code
- 54288
- Product ID
- 54288-140_4c9a6374-9e83-420d-bc29-20170bfbc6e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- BPI LABS LLC
- Application
- ANDA205600
- Marketing category
- ANDA
- Marketing start
- 2020-07-13
- Substance
- LEVOFLOXACIN
- Active strength
- 15 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 | 15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 545118 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54288-140-01 | Levofloxacin | 5 mL in 1 CARTON | SOLUTION/ DROPS | 5 | | 8 |
| 54288-140-01 | Levofloxacin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54288-140 | LEVOFLOXACIN SOLUTION/ DROPS [BPI LABS LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250213_b6d9740b-2f9d-4f1c-bc9b-4c2150b22f10.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 |
|---|
| 54288-140-01 | 54288014001 | 1 CARTON in 1 CARTON (54288-140-01) / 5 mL in 1 CARTON | 1 carton | 2020-07-13 | 0000-00-00 | No | No | Current |