NDC 0409-0528-13 - 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
- 0409-0528
- Requested NDC
- 0409-0528-13
- Package NDCs from labels
- 0409-0528-13, 0409-0528-15, 0409-0528-23, 0409-0528-25, 0409-0528-31, 0409-0528-35
- Manufacturer
- Hospira, Inc.
- Effective date
- 2024-07-10
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| LEVOFLOXACIN - Hospira, Inc. | Hospira, Inc. | 2024-07-10 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0409-0528-13 | ML - Milliliter | 0409-0528 | 013298df-7b8b-4f7f-b569-f242723b8f92 | 1 | 2017-05-03 |
| 0409-0528-15 | ML - Milliliter | 0409-0528 | 97f8a2ab-60be-400d-a5ee-87ec35a15882 | 1 | 2017-05-03 |
| 0409-0528-23 | ML - Milliliter | 0409-0528 | 97b3e06a-c996-4acd-9c5d-a65daa28484c | 1 | 2017-05-03 |
| 0409-0528-25 | ML - Milliliter | 0409-0528 | d0ae828a-16ed-4696-a35c-efff56be261c | 1 | 2017-05-03 |
| 0409-0528-31 | ML - Milliliter | 0409-0528 | 3a48fd93-1a4e-46a6-b05c-e1aff56a85c1 | 1 | 2017-05-03 |
| 0409-0528-35 | ML - Milliliter | 0409-0528 | 7b0182fe-f9ed-4be4-84a6-99727eea713e | 1 | 2017-05-03 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| LEVOFLOXACIN | ACTIVE INGREDIENT | 6GNT3Y5LMF | LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| LEVOFLOXACIN ANHYDROUS | ACTIVE MOIETY | RIX4E89Y14 | LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| DEXTROSE | INACTIVE INGREDIENT | IY9XDZ35W2 | LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | LEVOFLOXACIN INJECTION, SOLUTION [HOSPIRA, INC.] | 1 |
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 |
|---|---|---|---|---|---|---|
| Dextrose | DEXTROSE MONOHYDRATE | Henry Schein, Inc. | 8cf6943f-16e8-4521-863c-09bb0b55e2a9 | 2026-09-09 | Warnings, Adverse reactions | LX22YL083G |
| Levofloxacin | LEVOFLOXACIN | Redpharm Drug | 5a65b2bc-9edc-f193-e063-6394a90a0104 | 2026-09-01 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Dextrose | DEXTROSE MONOHYDRATE | REMEDYREPACK INC. | b8b77421-d687-45aa-82f6-d49bce644c10 | 2026-08-31 | Warnings, Adverse reactions | LX22YL083G |
| levofloxacin | LEVOFLOXACIN | Coupler LLC | 59f387a4-4dfa-ba71-e063-6294a90a340c | 2026-08-26 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Major Pharmaceuticals | ac4001ca-882f-4d9b-a570-c1b9d7fd6830 | 2026-08-21 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 9f944b63-9b60-437a-ba57-d14d7976bc32 | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Dextrose and Sodium Chloride | DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE | Fresenius Kabi USA, LLC | df18a603-ca12-4b26-83b5-9dd07b6453ab | 2026-08-18 | Warnings, Adverse reactions | LX22YL083G |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | bbc5b820-4973-11e2-a192-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | LX22YL083G |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | c29bdfa0-4976-11e2-939b-0002a5d5c51b | 2026-08-18 | Warnings, Adverse reactions | LX22YL083G |
| DELFLEX | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care Renal Therapies Group, LLC | 515dcee0-3e34-11e2-a25f-0800200c9a66 | 2026-08-18 | Warnings, Adverse reactions | LX22YL083G |
| levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | b9dc8bf3-97d9-4d1c-9a68-3ae553acdada | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Delflex | DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE | Fresenius Medical Care de Mexico, S.A. de C.V. | a98facd6-9daa-4d37-8209-63a0599dbfaa | 2026-07-27 | Warnings, Adverse reactions | LX22YL083G |
| Levofloxacin | LEVOFLOXACIN | Sagent Pharmaceuticals | 699fbdb8-a6fd-476a-9b80-08197d869534 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | HAWAII REPACK, INC. | 857f256c-88ac-4f73-9815-c2724edf2f1e | 2026-07-18 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Dextrose | DEXTROSE MONOHYDRATE | Hospira, Inc. | 4ed365da-4e62-4329-c1b9-c197ab4fb6e1 | 2026-07-13 | Warnings, Adverse reactions | LX22YL083G |
| Infant Dextrose | DEXTROSE | Henry Schein, Inc. | ce71d929-d11e-444c-bd45-e025d5172057 | 2026-07-13 | Warnings, Adverse reactions | LX22YL083G |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 2a4e97e0-0709-411b-92e8-6f7d669412e4 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 710c0c10-89a5-4954-8f74-acc187c5cf0f | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | Chartwell RX, LLC | 5c6c117c-9d91-48f4-9aaa-ee70b99218c2 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | f14cf651-a213-4a4f-adb9-f628562af27c | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 6GNT3Y5LMF |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.