NDC 80425-0077-01 - Levofloxacin
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 80425-0077
- Requested NDC
- 80425-0077-01
- Package NDCs from labels
- 80425-0077-1, 80425-0077-01
- Manufacturer
- Advanced Rx of Tennessee, LLC
- Effective date
- 2024-12-31
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| Levofloxacin - Advanced Rx of Tennessee, LLC | Advanced Rx of Tennessee, LLC | 2024-12-31 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 80425-0077-1 | Levofloxacin | 14 in 1 BOTTLE | TABLET, FILM COATED | 14 | 6 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 80425-0077 | LEVOFLOXACIN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250101_b001d60e-b8fb-54ff-e053-2a95a90a2970.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 80425-0077-1 | EA - Each | 80425-0077 | 158c2c5f-2e17-4f7e-8612-036b1ce2260e | 1 | 2023-06-06 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 80501b71-2f08-2ef5-e053-2991aa0a6e86 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | ANDA202801 199885 6GNT3Y5LMF |
| levofloxacin | LEVOFLOXACIN | Coupler LLC | 2cee61b7-be51-0fe5-e063-6294a90af9e3 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | 199884 6GNT3Y5LMF |
| levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals Inc | 067e260c-dc47-4957-a9ff-5a79f17b4ca0 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 311296 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | DirectRx | dabedb15-5b55-3853-e053-2995a90aa44e | 2025-01-21 | Warnings, Adverse reactions | ANDA202801 311296 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | d98cf024-51fa-45a1-b247-da55aba88ca0 | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | ANDA202801 311296 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals,Inc. | 8423b021-e09c-4f1c-e053-2991aa0afef6 | 2025-01-02 | Boxed warning, Warnings, Adverse reactions | ANDA202801 311296 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af4b7333-4f77-4ec9-e053-2a95a90a16d2 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA202801 199885 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Advanced Rx of Tennessee, LLC | afd5cb35-4232-f8b1-e053-2a95a90a8c5b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 199885 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Advanced Rx of Tennessee, LLC | b001d60e-b8fb-54ff-e053-2a95a90a2970 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | ANDA202801 80425-0077-1 80425-0077 80425007701 311296 2a98d9c1-b778-40b1-e063-6294a90a20e4 b001d60e-b8fb-54ff-e053-2a95a90a2970 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | A-S Medication Solutions | bdc8b2cc-a914-4613-ac7c-e8dfe91dea13 | 2024-09-29 | Boxed warning, Warnings, Adverse reactions | ANDA202801 199885 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Golden State Medical Supply, Inc. | bfe280be-0789-69fa-e053-2a95a90a0e13 | 2024-09-16 | Boxed warning, Warnings, Adverse reactions | 199885 311296 199884 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 171ab6c6-8eb5-4716-926f-cee52b7d0968 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | ANDA202801 199884 6GNT3Y5LMF |
| LEVOFLOXACIN | LEVOFLOXACIN | Gland Pharma Limited | ba69722b-d7f2-4519-8a63-9ee91294c499 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 54a02488-586d-4c4e-8a35-68a067bdd6e3 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | ANDA202801 311296 6GNT3Y5LMF |
| levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | b7a614b0-f604-48e1-9919-21da8f939d93 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 199885 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | 804ec547-5b89-4fd0-89b3-7445543e563e | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | ANDA202801 199885 6GNT3Y5LMF |
| levofloxacin | LEVOFLOXACIN | Zydus Lifesciences Limited | ffa121b8-388f-4d7b-af48-d4aa8d9b5961 | 2024-08-16 | 199885 311296 199884 6GNT3Y5LMF | |
| Levofloxacin | LEVOFLOXACIN | Camber Pharmaceuticals, Inc. | b43e9b51-568c-4d84-bbd1-d237120056c4 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | ANDA202801 31722-723 199885 311296 199884 1fa0a846-34d8-d6f5-e063-6394a90a8e54 b43e9b51-568c-4d84-bbd1-d237120056c4 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | NuCare Pharmaceuticals, Inc. | 4a405103-41e8-6a1f-e054-00144ff8d46c | 2024-07-19 | Boxed warning, Warnings, Adverse reactions | ANDA202801 199884 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Lupin Pharmaceuticals, Inc. | 4be13bd5-0c39-43c3-9232-b1226ccd4dbc | 2024-07-10 | Boxed warning, Warnings, Adverse reactions | 199885 311296 199884 6GNT3Y5LMF |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.