levofloxacin
- Product NDC
- 72578-099
- 11-digit product format
- 725780099
- Labeler code
- 72578
- Product ID
- 72578-099_6295ff00-86a9-454c-987b-a1fe1c4386e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Viona Pharmaceuticals Inc
- Application
- ANDA077652
- Marketing category
- ANDA
- Marketing start
- 2022-01-10
- Substance
- LEVOFLOXACIN
- Active strength
- 500 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 | 500 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 |
|---|
| 72578-099-01 | levofloxacin | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | | 3 |
| 72578-099-05 | levofloxacin | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 3 |
| 72578-099-10 | levofloxacin | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 3 |
| 72578-099-18 | levofloxacin | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72578-099 | LEVOFLOXACIN TABLET, FILM COATED [VIONA PHARMACEUTICALS INC] | 3 | Current NDC, Legacy NDC, 4 package rows | 20240629_0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2.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 |
|---|
| 72578-099-01 | 72578009901 | 100 TABLET, FILM COATED in 1 BOTTLE (72578-099-01) | 2022-01-10 | 0000-00-00 | Yes | No | Current |
| 72578-099-05 | 72578009905 | 500 TABLET, FILM COATED in 1 BOTTLE (72578-099-05) | 2022-01-10 | 0000-00-00 | Yes | No | Current |
| 72578-099-10 | 72578009910 | 1000 TABLET, FILM COATED in 1 BOTTLE (72578-099-10) | 2022-01-10 | 0000-00-00 | Yes | No | Current |
| 72578-099-18 | 72578009918 | 50 TABLET, FILM COATED in 1 BOTTLE (72578-099-18) | 2022-01-10 | 0000-00-00 | Yes | No | Current |