LEVOFLOXACIN
- Product NDC
- 68083-394
- 11-digit product format
- 680830394
- Labeler code
- 68083
- Product ID
- 68083-394_949f1c99-7067-450e-bc22-504f5aed0de9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEVOFLOXACIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA205540
- Marketing category
- ANDA
- Marketing start
- 2020-04-22
- Substance
- LEVOFLOXACIN
- Active strength
- 25 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 | 25 mg/mL |
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 |
|---|
| 68083-394-01 | LEVOFLOXACIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 68083-394-01 | LEVOFLOXACIN | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-394 | LEVOFLOXACIN INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240910_ba69722b-d7f2-4519-8a63-9ee91294c499.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 |
|---|
| 68083-394-01 | 68083039401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE | 2020-04-22 | 0000-00-00 | No | No | Current |