Levofloxacin
- Product NDC
- 43063-459
- 11-digit product format
- 430630459
- Labeler code
- 43063
- Product ID
- 43063-459_413846f3-6d6b-3731-e063-6394a90afd7f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA201043
- Marketing category
- ANDA
- Marketing start
- 2011-06-20
- Substance
- LEVOFLOXACIN
- Active strength
- 750 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A201043-001 | LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | |
| A201043-002 | LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | |
| A201043-003 | LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A201043-001 | AB |
| A201043-002 | AB |
| A201043-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201043-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2011-06-20 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201043-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | RS | 2011-06-20 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201043-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2011-06-20 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A201043-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201043-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A201043-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201043-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201043-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A201043-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A201043-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201043-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A201043-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201043-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201043-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A201043-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201043-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201043-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A201043-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201043-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201043-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A201043-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201043-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201043-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A201043-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201043-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201043-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A201043-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201043-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201043-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A201043-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A201043-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201043-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A201043-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201043-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201043-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A201043-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201043-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201043-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A201043-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201043-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201043-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A201043-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A201043-001 | AB | 1 | 8072bd15b7f6… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Levofloxacin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| LEVOFLOXACIN | 750 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6GNT3Y5LMF | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 311296 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 814450ae-439e-4a5d-8c60-9b21b6f14be5 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| addb5519-f7ae-4d4e-b9ca-f782a1597fd3 | Product name | 2 | 20210610 |
| fb758c6a-fdee-40a8-99c2-46f79c3ff90c | Product name | 4 | 20200807 |
| 1a81e9a9-11c3-4fcf-b5dd-f6798fef8e6d | Product name | 1 | 20190618 |
| aea4a616-4dfe-45f6-94bb-8b9063056ceb | Product name | 6 | 20190611 |
| 2246ce8e-a477-4dc3-b6d6-fe9973c18ed1 | Product name | 1 | 20180821 |
| 5a6c788d-375b-4565-a8ae-67c179a30c93 | Product name | 1 | 20180212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43063-459-05 | Levofloxacin | 5 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 5 | 21 | |
| 43063-459-07 | Levofloxacin | 7 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 7 | 21 | |
| 43063-459-10 | Levofloxacin | 10 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 10 | 21 | |
| 43063-459-20 | Levofloxacin | 20 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 20 | 21 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43063-459-05 | EA - Each | 43063-459 | a4e22098-2b4a-41da-868a-0e68449af7e3 | 1 | 2015-08-04 |
| 43063-459-07 | EA - Each | 43063-459 | 769a015a-e7ec-4a19-bf4b-555c716f3603 | 1 | 2013-08-02 |
| 43063-459-10 | EA - Each | 43063-459 | 0d7a3ae0-a1d6-43ac-924c-6b6825a43eca | 1 | 2015-08-04 |
| 43063-459-20 | EA - Each | 43063-459 | a2dea678-2295-44ba-bdb1-dc94b6666948 | 1 | 2016-01-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 | HAWAII REPACK, INC. | 857f256c-88ac-4f73-9815-c2724edf2f1e | 2026-07-18 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 9f944b63-9b60-437a-ba57-d14d7976bc32 | 2026-05-07 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | a5ae33ad-4703-4cb2-8618-6439c906be99 | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 814450ae-439e-4a5d-8c60-9b21b6f14be5 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 43063-459 |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | b1a4aabb-42af-4133-8e82-0c7ec8fa79c3 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | PD-Rx Pharmaceuticals, Inc. | b8defac4-9deb-433b-928e-0ef4ee0123a2 | 2025-10-02 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | Advanced Rx of Tennessee, LLC | afd5cb35-4232-f8b1-e053-2a95a90a8c5b | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | Aurobindo Pharma Limited | 529ac72c-c4a0-4001-8cf9-b94f5bf7265c | 2024-06-20 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | Asclemed USA, Inc. | 2e32a8aa-047b-46c6-b67b-d88a9a0a810b | 2024-05-13 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
| Levofloxacin | LEVOFLOXACIN | Proficient Rx LP | 30958610-3803-45e6-aa3c-d256decbe6e4 | 2019-10-01 | Boxed warning, Warnings, Adverse reactions | 201043 ANDA201043 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311296 | levoFLOXacin 750 MG Oral Tablet | PSN | 814450ae-439e-4a5d-8c60-9b21b6f14be5 | 21 |
| 311296 | levofloxacin 750 MG Oral Tablet | SCD | 814450ae-439e-4a5d-8c60-9b21b6f14be5 | 21 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 43063-459-05 | 43063045905 | 5 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-05) | 2012-09-25 | 0000-00-00 | No | No | Current |
| 43063-459-07 | 43063045907 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-07) | 2012-09-25 | 0000-00-00 | No | No | Current |
| 43063-459-10 | 43063045910 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-10) | 2012-09-25 | 0000-00-00 | No | No | Current |
| 43063-459-20 | 43063045920 | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-459-20) | 2012-09-25 | 0000-00-00 | No | No | Current |