MOXIFLOXACIN HYDROCHLORIDE
- Product NDC
- 65862-603
- 11-digit product format
- 658620603
- Labeler code
- 65862
- Product ID
- 65862-603_412cb5bf-66ad-4815-bf15-8d225c09260b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- moxifloxacin hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA202632
- Marketing category
- ANDA
- Marketing start
- 2014-03-04
- Substance
- MOXIFLOXACIN HYDROCHLORIDE
- Active strength
- 400 mg/1
- Pharmacologic classes
- Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| unfinished product | product | 65862-603 | UNFINISHED | Active or certified unfinished drug listing | 2026-09-14 | ||
| unfinished package | package | 65862-603 | 65862-603-26 | UNFINISHED | Active or certified unfinished drug listing | 2026-09-14 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished product | product | a6255e0c9aa5… | a0211a219f2e… | |
| 2025-12-14 21:27 UTC · source 2025-12-05 | unfinished package | package | 65862-603-26 | a6255e0c9aa5… | a0211a219f2e… |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished product | product | 1d862106b807… | 00c93037cd84… | |
| 2025-08-26 23:59 UTC · source 2025-08-26 | unfinished package | package | 65862-603-26 | 1d862106b807… | 00c93037cd84… |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished product | product | 390b4c401c3f… | 2c692c2daee3… | |
| 2025-05-15 14:59 UTC · source 2025-05-14 | unfinished package | package | 65862-603-26 | 390b4c401c3f… | 2c692c2daee3… |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished product | product | e30019b0c005… | a3f0b14938b7… | |
| 2025-04-01 07:37 UTC · source 2025-03-31 | unfinished package | package | 65862-603-26 | e30019b0c005… | a3f0b14938b7… |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished product | product | bbbc9f937eca… | 946b9c97cf81… | |
| 2025-03-01 13:19 UTC · source 2025-02-28 | unfinished package | package | 65862-603-26 | bbbc9f937eca… | 946b9c97cf81… |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished product | product | f268b84574a6… | 26285f5ac5df… | |
| 2025-02-27 05:24 UTC · source 2025-02-26 | unfinished package | package | 65862-603-26 | f268b84574a6… | 26285f5ac5df… |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished product | product | f764e8902f78… | 92046438deef… | |
| 2025-02-01 13:13 UTC · source 2025-01-31 | unfinished package | package | 65862-603-26 | f764e8902f78… | 92046438deef… |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished product | product | 68b1e3bced9e… | 98a755eb8bc6… | |
| 2025-01-20 13:05 UTC · source 2025-01-17 | unfinished package | package | 65862-603-26 | 68b1e3bced9e… | 98a755eb8bc6… |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished product | product | 05c55d027831… | ca05dca9dc4c… | |
| 2024-11-29 20:42 UTC · source 2024-11-29 | unfinished package | package | 65862-603-26 | 05c55d027831… | ca05dca9dc4c… |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished product | product | 48b4f40e6753… | c7c7a00d2afa… | |
| 2024-11-09 02:36 UTC · source 2024-11-08 | unfinished package | package | 65862-603-26 | 48b4f40e6753… | c7c7a00d2afa… |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished product | product | 27f29a85d7e4… | 1372111e901f… | |
| 2024-10-09 02:27 UTC · source 2024-10-08 | unfinished package | package | 65862-603-26 | 27f29a85d7e4… | 1372111e901f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished product | product | 8d62ce987f31… | 9fe9ef23e30d… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | unfinished package | package | 65862-603-26 | 8d62ce987f31… | 9fe9ef23e30d… |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished product | product | d1e113ab4d42… | 063ee3eb0a1d… | |
| 2024-05-28 21:11 UTC · source 2024-05-28 | unfinished package | package | 65862-603-26 | d1e113ab4d42… | 063ee3eb0a1d… |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished product | product | 50b4072663b7… | eae3003ed65e… | |
| 2024-05-15 03:51 UTC · source 2024-05-14 | unfinished package | package | 65862-603-26 | 50b4072663b7… | eae3003ed65e… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished product | product | 906f6e251498… | bf70b80e44f0… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | unfinished package | package | 65862-603-26 | 906f6e251498… | bf70b80e44f0… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished product | product | 6db9cb8d1e19… | 3449e1ec5b70… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | unfinished package | package | 65862-603-26 | 6db9cb8d1e19… | 3449e1ec5b70… |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished product | product | 8fc7167e32ce… | e96bbc724034… | |
| 2021-02-18 23:40 UTC · source 2021-02-18 | unfinished package | package | 65862-603-26 | 8fc7167e32ce… | e96bbc724034… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished product | product | 4184dd79f89f… | 545327b3e20f… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | unfinished package | package | 65862-603-26 | 4184dd79f89f… | 545327b3e20f… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished product | product | 4bd3596a7b87… | 5c64c6f6865f… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | unfinished package | package | 65862-603-26 | 4bd3596a7b87… | 5c64c6f6865f… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished product | product | 263afe128892… | 91768de4ddbe… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | unfinished package | package | 65862-603-26 | 263afe128892… | 91768de4ddbe… |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished product | product | 5b2001dcd8f5… | 54b53d4dc9e4… | |
| 2019-06-01 22:24 UTC · source 2019-05-30 | unfinished package | package | 65862-603-26 | 5b2001dcd8f5… | 54b53d4dc9e4… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202632-001 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A202632-001 | MOXIFLOXACIN HYDROCHLORIDE | EQ 400MG BASE | TABLET / ORAL | AB | 2014-03-04 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A202632-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A202632-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A202632-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202632-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202632-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202632-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202632-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202632-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202632-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202632-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A202632-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A202632-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A202632-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A202632-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A202632-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A202632-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A202632-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A202632-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A202632-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A202632-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A202632-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A202632-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A202632-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A202632-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A202632-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A202632-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A202632-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A202632-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A202632-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A202632-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A202632-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A202632-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A202632-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A202632-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A202632-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A202632-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A202632-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A202632-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A202632-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A202632-001 | AB | 1 | f41ea6bd6efb… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MOXIFLOXACIN HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| MOXIFLOXACIN HYDROCHLORIDE | 400 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C53598599T | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 311787 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d6789c17-4a2f-4519-9060-e3b0dba422f0 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 84b851da-be59-d750-14d1-e4d93cc3b4da | Product name | 9 | 20250630 |
| 2194a6ab-15bb-de49-cced-f09e642b1b64 | Product name | 8 | 20240313 |
| d7840f4c-f22a-4403-b5da-53ac6ac8fd90 | Product name | 1 | 20150728 |
| ccc7bb05-654a-45d2-a0d6-09ab96ba531b | Product name | 2 | 20150611 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65862-603-10 | MOXIFLOXACIN HYDROCHLORIDE | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | 17 | |
| 65862-603-30 | MOXIFLOXACIN HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 17 | |
| 65862-603-55 | MOXIFLOXACIN HYDROCHLORIDE | 50 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 50 | 17 | |
| 65862-603-99 | MOXIFLOXACIN HYDROCHLORIDE | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 17 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65862-603-30 | EA - Each | 65862-603 | 3ea07df5-d4cb-42b0-96e6-d47f01ba0705 | 1 | 2014-04-03 |
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 |
|---|---|---|---|---|---|---|
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | American Health Packaging | 1ed191f5-7df5-488c-bb72-91ac0b618d9a | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | REMEDYREPACK INC. | bd0c0690-ba48-41c5-b76b-b1a53c36f424 | 2026-05-18 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | AvPAK | 371ca7b2-c62d-ef4b-3076-890b385bfff8 | 2026-04-07 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | be5b7a6f-9ee3-4453-807e-4761fffff60c | 2026-02-26 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 1a98b20d-c4a1-4184-8387-a4866d1d62bf | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 18b77b31-baf3-416f-b3b7-a631c8e46d20 | 2026-02-16 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | 6cd420c3-113e-4fc2-b59f-bfc7c485c14d | 2026-02-02 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | Major Pharmaceuticals | 815d71cf-02de-4190-9bd1-3fdc67ef0f06 | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | ac8a81b9-2fed-412a-8c83-db8dee1061f6 | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | Rising Pharma Holdings, Inc. | f34c08e6-fe74-4de3-9e36-a82c3c1c183b | 2025-10-10 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 37466c79-8726-4fd6-9412-0bb83d523fe3 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | Aurobindo Pharma Limited | d6789c17-4a2f-4519-9060-e3b0dba422f0 | 2025-09-01 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 65862-603 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | REMEDYREPACK INC. | 54377276-96bf-4140-9e90-55623ab6b013 | 2025-08-27 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| MOXIFLOXACIN HYDROCHLORIDE | MOXIFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 02c29e8e-8346-4e28-b7fc-2f4cb61ad37d | 2024-09-18 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
| Moxifloxacin Hydrochloride | MOXIFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | c71e5987-edd7-4c38-b646-3e48a6e51bf4 | 2023-11-14 | Boxed warning, Warnings, Adverse reactions | 202632 ANDA202632 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 6cd420c3-113e-4fc2-b59f-bfc7c485c14d | 104 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 6cd420c3-113e-4fc2-b59f-bfc7c485c14d | 104 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 6cd420c3-113e-4fc2-b59f-bfc7c485c14d | 104 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 18b77b31-baf3-416f-b3b7-a631c8e46d20 | 20 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 1a98b20d-c4a1-4184-8387-a4866d1d62bf | 20 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 18b77b31-baf3-416f-b3b7-a631c8e46d20 | 20 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 1a98b20d-c4a1-4184-8387-a4866d1d62bf | 20 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 18b77b31-baf3-416f-b3b7-a631c8e46d20 | 20 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 1a98b20d-c4a1-4184-8387-a4866d1d62bf | 20 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | d6789c17-4a2f-4519-9060-e3b0dba422f0 | 17 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | d6789c17-4a2f-4519-9060-e3b0dba422f0 | 17 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | d6789c17-4a2f-4519-9060-e3b0dba422f0 | 17 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 1ed191f5-7df5-488c-bb72-91ac0b618d9a | 10 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 1ed191f5-7df5-488c-bb72-91ac0b618d9a | 10 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 1ed191f5-7df5-488c-bb72-91ac0b618d9a | 10 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | bd0c0690-ba48-41c5-b76b-b1a53c36f424 | 9 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | bd0c0690-ba48-41c5-b76b-b1a53c36f424 | 9 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | bd0c0690-ba48-41c5-b76b-b1a53c36f424 | 9 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 371ca7b2-c62d-ef4b-3076-890b385bfff8 | 6 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 371ca7b2-c62d-ef4b-3076-890b385bfff8 | 6 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 371ca7b2-c62d-ef4b-3076-890b385bfff8 | 6 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 815d71cf-02de-4190-9bd1-3fdc67ef0f06 | 3 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 815d71cf-02de-4190-9bd1-3fdc67ef0f06 | 3 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 815d71cf-02de-4190-9bd1-3fdc67ef0f06 | 3 |
| 311787 | moxifloxacin HCl 400 MG Oral Tablet | PSN | 02c29e8e-8346-4e28-b7fc-2f4cb61ad37d | 1 |
| 311787 | moxifloxacin 400 MG Oral Tablet | SCD | 02c29e8e-8346-4e28-b7fc-2f4cb61ad37d | 1 |
| 311787 | moxifloxacin (as moxifloxacin HCl) 400 MG Oral Tablet | SY | 02c29e8e-8346-4e28-b7fc-2f4cb61ad37d | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65862-603-10 | 65862060310 | 1 in 1 BLISTER PACK | Historical | |||||
| 65862-603-26 | 65862060326 | 2500 TABLET, FILM COATED in 1 BAG (65862-603-26) | 04-MAR-14 | Current | ||||
| 65862-603-30 | 65862060330 | 30 TABLET, FILM COATED in 1 BOTTLE (65862-603-30) | 2014-03-04 | 0000-00-00 | No | No | Current | |
| 65862-603-55 | 65862060355 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (65862-603-55) / 1 TABLET, FILM COATED in 1 BLISTER PACK (65862-603-10) | 50 blister pack | 2014-03-04 | 0000-00-00 | No | No | Current |
| 65862-603-99 | 65862060399 | 1000 TABLET, FILM COATED in 1 BOTTLE (65862-603-99) | 2014-03-04 | 0000-00-00 | No | No | Current |