Levofloxacin
- Product NDC
- 65862-536
- 11-digit product format
- 658620536
- Labeler code
- 65862
- Product ID
- 65862-536_00620274-6cae-4cb8-bd5d-8f80732ae3ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA201043
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- Substance
- LEVOFLOXACIN
- Active strength
- 250 mg/1
- 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 | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 199884, 199885, 311296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65862-536-10 | Levofloxacin | 10 in 1 BLISTER PACK | TABLET, FILM COATED | 10 | | 23 |
| 65862-536-10 | Levofloxacin | 10 in 1 CARTON | TABLET, FILM COATED | 10 | | 23 |
| 65862-536-50 | Levofloxacin | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 23 |
| 65862-536-99 | Levofloxacin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 23 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65862-536 | LEVOFLOXACIN TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | 23 | Current NDC, Legacy NDC, 4 package rows | 20240630_529ac72c-c4a0-4001-8cf9-b94f5bf7265c.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 |
|---|
| 65862-536-10 | 65862053610 | 10 BLISTER PACK in 1 CARTON (65862-536-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 10 blister pack | 2011-06-20 | 0000-00-00 | No | No | Current |
| 65862-536-22 | 65862053622 | 2000 TABLET, FILM COATED in 1 BAG (65862-536-22) | | 20-JUN-11 | | | | Current |
| 65862-536-50 | 65862053650 | 50 TABLET, FILM COATED in 1 BOTTLE (65862-536-50) | | 2011-06-20 | 0000-00-00 | No | No | Current |
| 65862-536-60 | 65862053660 | 60000 TABLET, FILM COATED in 1 BAG (65862-536-60) | | 07-JAN-22 | | | | Current |
| 65862-536-99 | 65862053699 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-536-99) | | 2011-06-20 | 0000-00-00 | No | No | Current |