levofloxacin
- Product NDC
- 63629-7050
- Requested package NDC
- 63629-7050-4
- 11-digit product format
- 636297050
- Labeler code
- 63629
- Product ID
- 63629-7050_bdb63778-1504-49e8-afcf-dc577e6aa7dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- levofloxacin
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA077652
- Marketing category
- ANDA
- Marketing start
- 2012-11-10
- Marketing end
- 0000-00-00
- Substance
- LEVOFLOXACIN
- Active strength
- 750 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 63629-7050 | 63629-7050-4 | D | Discontinued by firm | 2026-08-03 |
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-7050 | 63629-7050-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-7050 | 63629-7050-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | 0efc9e666f02… | f202fb6c5f17… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-7050 | 63629-7050-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | ad56d346431e… | cc804d4bbf1e… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-7050 | 63629-7050-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-7050 | 63629-7050-4 | D | Discontinued by firm | excluded / ndc_excluded.zip | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 63629-7050 | 63629-7050-4 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077652-001 | LEVOFLOXACIN | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | |
| A077652-002 | LEVOFLOXACIN | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | |
| A077652-003 | LEVOFLOXACIN | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077652-001 | AB |
| A077652-002 | AB |
| A077652-003 | 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 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077652-002 | LEVOFLOXACIN | 500MG | TABLET / ORAL | AB | 2012-09-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077652-003 | LEVOFLOXACIN | 750MG | TABLET / ORAL | AB | 2012-09-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077652-001 | LEVOFLOXACIN | 250MG | TABLET / ORAL | AB | 2012-09-07 | 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 | A077652-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077652-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A077652-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077652-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077652-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077652-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077652-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077652-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A077652-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077652-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077652-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077652-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077652-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077652-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077652-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077652-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077652-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077652-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077652-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077652-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077652-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077652-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077652-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077652-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077652-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077652-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077652-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077652-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077652-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A077652-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077652-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077652-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077652-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077652-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077652-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077652-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077652-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077652-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077652-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077652-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| levofloxacin | LEVOFLOXACIN | Redpharm Drug | 5261da15-1b6c-fbe2-e063-6394a90ad85e | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Redpharm Drug | 44f31105-5fc9-43d4-e063-6294a90a510f | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | REMEDYREPACK INC. | 264a3f71-f23e-45e3-926a-421bcccf4e3d | 2026-02-05 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals Inc. | 7a12135e-cbad-4fe1-98f7-53c41d1f2a21 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Redpharm Drug | 301ecffc-ecaf-01de-e063-6294a90a61b3 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | cbd5153f-fada-4682-b858-dc3b6e3173cc | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Coupler LLC | 2cee61b7-be51-0fe5-e063-6294a90af9e3 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Preferred Pharmaceuticals Inc | 067e260c-dc47-4957-a9ff-5a79f17b4ca0 | 2025-01-23 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Bryant Ranch Prepack | b7a614b0-f604-48e1-9919-21da8f939d93 | 2024-08-26 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| levofloxacin | LEVOFLOXACIN | Zydus Lifesciences Limited | ffa121b8-388f-4d7b-af48-d4aa8d9b5961 | 2024-08-16 | 077652 ANDA077652 | |
| levofloxacin | LEVOFLOXACIN | Viona Pharmaceuticals Inc | 0948bff7-efc6-4f0e-a9dd-adca5bdc7fc2 | 2024-06-25 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
| Levofloxacin | LLEVOFLOXACIN | Advanced Rx Pharmacy of Tennessee, LLC | 19afbe98-484c-c980-e063-6294a90acdc6 | 2024-05-22 | Boxed warning, Warnings, Adverse reactions | 077652 ANDA077652 |
FDA-Initiated Inactive NDC Indexing#
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-7050-4 | 63629705004 | 5 TABLET, FILM COATED in 1 BOTTLE (63629-7050-4) | 2016-07-28 | 0000-00-00 | No | No | Current |