Levofloxacin
- Product NDC
- 44567-435
- 11-digit product format
- 445670435
- Labeler code
- 44567
- Product ID
- 44567-435_e6bfbccc-f54c-4d4d-b268-b4fc803e372b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- WG Critical Care, LLC
- Application
- ANDA090343
- Marketing category
- ANDA
- Marketing start
- 2016-04-14
- 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 |
|---|
| 44567-435-24 | Levofloxacin | 24 in 1 CARTON | INJECTION, SOLUTION | 24 | | 11 |
| 44567-435-24 | Levofloxacin | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 44567-435 | LEVOFLOXACIN INJECTION, SOLUTION [WG CRITICAL CARE, LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20250206_9020cdeb-65fe-458f-bbbd-69265a49906e.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 |
|---|
| 44567-435-24 | 44567043524 | 24 POUCH in 1 CARTON (44567-435-24) / 1 BAG in 1 POUCH / 50 mL in 1 BAG | 24 pouch | 2016-04-14 | 0000-00-00 | No | No | Current |