Levofloxacin
- Product NDC
- 80425-0008
- 11-digit product format
- 804250008
- Labeler code
- 80425
- Product ID
- 80425-0008_2a981e22-d7c9-311b-e063-6294a90ab25f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx of Tennessee, LLC
- Application
- ANDA201043
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- 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 | 199885 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0008-1 | Levofloxacin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 6 |
| 80425-0008-2 | Levofloxacin | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0008 | LEVOFLOXACIN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250101_afd5cb35-4232-f8b1-e053-2a95a90a8c5b.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 |
|---|
| 80425-0008-1 | 80425000801 | 14 TABLET, FILM COATED in 1 BOTTLE (80425-0008-1) | 2011-06-20 | 0000-00-00 | No | No | Current |
| 80425-0008-2 | 80425000802 | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0008-2) | 2011-06-20 | 0000-00-00 | No | No | Current |