Ciprofloxacin

Product NDC
0440-6290
11-digit product format
004406290
Labeler code
0440
Product ID
0440-6290_fa6108be-f4de-41b6-991a-902414a8548a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Liberty Pharmaceuticals, Inc.
Application
ANDA076126
Marketing category
ANDA
Marketing start
2009-10-10
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0440-6290DDiscontinued by firm2026-08-03
excluded packagepackage0440-62900440-6290-85DDiscontinued by firm2026-08-03

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.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0440-6290-85d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0440-6290-85f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0440-6290-852ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0440-6290-85a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0440-6290-85cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0440-6290-85cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0440-6290-85302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0440-6290-85ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0440-6290-850efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0440-6290-85ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0440-6290-85367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0440-6290-85557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076126-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09
A076126-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09
A076126-004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A076126-002AB
A076126-003AB
A076126-004AB

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.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076126-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076126-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076126-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076126-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076126-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076126-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076126-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076126-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076126-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076126-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076126-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076126-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076126-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076126-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076126-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076126-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076126-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076126-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076126-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076126-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076126-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076126-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076126-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076126-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076126-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076126-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076126-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076126-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076126-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076126-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076126-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076126-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076126-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076126-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076126-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076126-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076126-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076126-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076126-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076126-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076126-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076126-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076126-002AB18072bd15b7f6…

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.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.74e2dd24-5c6e-4dde-a2ab-f2d2e61734d82025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.cfda82e4-8660-447e-a881-b87165a31e9a2025-11-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions1dca6149-00ca-480e-a887-6861e40803b92025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions6e37322b-89d3-4b66-8e1b-c4ad79eed1732025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.bb2edaca-6cf2-4100-83f5-8ce142f68e592025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackd6bd5021-cf56-4c8a-b5a0-bbc8919740af2025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepack99918613-7936-47dd-8565-9cd6c0cc22e32025-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEGolden State Medical Supply, Inc.d17b0e87-b555-4dfb-e053-2a95a90aa5ef2025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEGolden State Medical Supply, Inc.1b54c195-71ba-2523-e063-6294a90ada732025-02-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDECarlsbad Technology, Inc.37527eca-115e-4582-88cd-bba851ac60692025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepackb283d662-9be1-49c7-be03-cb21055314c12024-10-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEBryant Ranch Prepack8eef4f14-e7ef-41be-be57-7993b333e8a92023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEDenton Pharma, Inc. DBA Northwind Pharmaceuticalsde0b9579-fb85-e1ce-e053-2a95a90aeecb2023-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPa093ca6e-9963-4eea-b60d-6e2f148192ec2022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLCdf24efa3-c9a0-4f40-92ce-cc71c708931b2018-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126
CiprofloxacinCIPROFLOXACINAphena Pharma Solutions - Tennessee, LLCc7bc0d20-526c-48ea-b23a-cea9eb7080ff2018-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076126
application number: ANDA076126