levofloxacin
- Product NDC
- 68083-415
- 11-digit product format
- 680830415
- Labeler code
- 68083
- Product ID
- 68083-415_7df12e53-0519-4d42-b89f-dbe83b7e7e7d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA206908
- Marketing category
- ANDA
- Marketing start
- 2020-12-30
- Substance
- LEVOFLOXACIN
- Active strength
- 500 mg/100mL
- 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/100mL |
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 |
|---|
| 68083-415-01 | levofloxacin | 1 in 1 POUCH | INJECTION, SOLUTION | 1 | | 4 |
| 68083-415-01 | levofloxacin | 100 mL in 1 BAG | INJECTION, SOLUTION | 100 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-415 | LEVOFLOXACIN INJECTION, SOLUTION LEVOFLOXACIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240705_95479f18-76dc-41cf-a359-922febeed0f2.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 |
|---|
| 68083-415-01 | 68083041501 | 1 BAG in 1 POUCH (68083-415-01) / 100 mL in 1 BAG | 1 bag | 2020-12-30 | 0000-00-00 | No | No | Current |