Ciprofloxacin
- Product NDC
- 63629-8344
- 11-digit product format
- 636298344
- Labeler code
- 63629
- Product ID
- 63629-8344_361f92c1-054a-4661-b3b9-fdd0782f5c01
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ciprofloxacin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA076126
- Marketing category
- ANDA
- Marketing start
- 2009-10-10
- Marketing end
- 0000-00-00
- Substance
- CIPROFLOXACIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Quinolone Antimicrobial [EPC],Quinolones [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
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 |
|---|---|---|---|---|---|---|---|
| excluded product | product | 63629-8344 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 63629-8344 | 63629-8344-1 | D | Discontinued by firm | 2026-08-03 |
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 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 63629-8344-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 63629-8344-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 63629-8344-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 63629-8344-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 63629-8344-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 63629-8344-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 63629-8344-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 63629-8344-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 63629-8344-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 63629-8344-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 63629-8344-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 63629-8344-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | |
| A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | |
| A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076126-002 | AB |
| A076126-003 | AB |
| A076126-004 | 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 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076126-003 | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET / ORAL | AB | 2004-06-09 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076126-004 | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET / ORAL | AB | 2004-06-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076126-002 | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET / ORAL | AB | 2004-06-09 | 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 | A076126-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076126-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076126-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076126-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076126-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076126-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076126-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076126-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076126-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076126-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076126-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076126-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076126-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076126-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076126-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076126-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076126-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076126-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076126-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076126-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076126-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076126-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076126-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076126-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076126-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076126-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076126-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076126-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076126-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076126-004 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076126-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076126-003 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076126-004 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076126-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076126-003 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076126-004 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076126-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076126-003 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076126-004 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076126-002 | AB | 1 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Ciprofloxacin | CIPROFLOXACIN | PD-Rx Pharmaceuticals, Inc. | 74e2dd24-5c6e-4dde-a2ab-f2d2e61734d8 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | cfda82e4-8660-447e-a881-b87165a31e9a | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 1dca6149-00ca-480e-a887-6861e40803b9 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | A-S Medication Solutions | 6e37322b-89d3-4b66-8e1b-c4ad79eed173 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | bb2edaca-6cf2-4100-83f5-8ce142f68e59 | 2025-04-30 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | d6bd5021-cf56-4c8a-b5a0-bbc8919740af | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | 99918613-7936-47dd-8565-9cd6c0cc22e3 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | d17b0e87-b555-4dfb-e053-2a95a90aa5ef | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Golden State Medical Supply, Inc. | 1b54c195-71ba-2523-e063-6294a90ada73 | 2025-02-24 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Carlsbad Technology, Inc. | 37527eca-115e-4582-88cd-bba851ac6069 | 2025-02-05 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | b283d662-9be1-49c7-be03-cb21055314c1 | 2024-10-24 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Bryant Ranch Prepack | 8eef4f14-e7ef-41be-be57-7993b333e8a9 | 2023-05-23 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | de0b9579-fb85-e1ce-e053-2a95a90aeecb | 2023-01-01 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Proficient Rx LP | a093ca6e-9963-4eea-b60d-6e2f148192ec | 2022-07-01 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | df24efa3-c9a0-4f40-92ce-cc71c708931b | 2018-10-31 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
| Ciprofloxacin | CIPROFLOXACIN | Aphena Pharma Solutions - Tennessee, LLC | c7bc0d20-526c-48ea-b23a-cea9eb7080ff | 2018-07-09 | Boxed warning, Warnings, Adverse reactions | 076126 ANDA076126 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 63629-8344-1 | 63629834401 | 20 TABLET, FILM COATED in 1 BOTTLE (63629-8344-1) | 2020-08-20 | 0000-00-00 | No | No | Current |