Levofloxacin
- Product NDC
- 55150-156
- 11-digit product format
- 551500156
- Labeler code
- 55150
- Product ID
- 55150-156_2a91fee4-6952-42e2-8326-c2d4233d11d3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA202328
- Marketing category
- ANDA
- Marketing start
- 2013-01-24
- Substance
- LEVOFLOXACIN
- Active strength
- 500 mg/20mL
- 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 | 500 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 1665517, 1665519 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-156-20 | Levofloxacin | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | | 13 |
| 55150-156-20 | Levofloxacin | 20 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION, CONCENTRATE | 20 | | 13 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] | 6 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [AUROMEDICS PHARMA LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-156 | LEVOFLOXACIN INJECTION, SOLUTION, CONCENTRATE [EUGIA US LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240622_4d400bf9-988f-42ec-93f1-e71a93a324b2.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-156-20 | 55150015620 | 1 VIAL, SINGLE-USE in 1 CARTON (55150-156-20) / 20 mL in 1 VIAL, SINGLE-USE | 2013-01-24 | 0000-00-00 | No | No | Current |