Levofloxacin
- Product NDC
- 80425-0388
- 11-digit product format
- 804250388
- Labeler code
- 80425
- Product ID
- 80425-0388_19afd937-88a9-275c-e063-6294a90aa35c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lLevofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- Application
- ANDA077652
- Marketing category
- ANDA
- Marketing start
- 2024-05-22
- Substance
- LEVOFLOXACIN
- Active strength
- 750 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 | 750 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 6GNT3Y5LMF |
| Rxcui | 311296 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 80425-0388-1 | Levofloxacin | 7 in 1 BOTTLE | TABLET, FILM COATED | 7 | | 1 |
| 80425-0388-2 | Levofloxacin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0388 | LEVOFLOXACIN (LLEVOFLOXACIN) TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 1 | Current NDC, 2 package rows | 20240601_19afbe98-484c-c980-e063-6294a90acdc6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 80425-0388-1 | 80425038801 | 7 TABLET, FILM COATED in 1 BOTTLE (80425-0388-1) | 2024-05-22 | No | No | Historical |
| 80425-0388-2 | 80425038802 | 14 TABLET, FILM COATED in 1 BOTTLE (80425-0388-2) | 2024-05-22 | No | No | Historical |