Ciprofloxacin

Product NDC
55154-3368
11-digit product format
551543368
Labeler code
55154
Product ID
55154-3368_8bca6829-da32-42fe-b2b7-4bdfb9a89e43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health
Application
ANDA076558
Marketing category
ANDA
Marketing start
2004-06-09
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
2023-12-31
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 productproduct55154-3368DDiscontinued by firm2026-08-03
excluded packagepackage55154-336855154-3368-0DDiscontinued 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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct55154-3368DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55154-336855154-3368-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A076558-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09
A076558-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09
A076558-004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09

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 UTC2026-02A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076558-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-098072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076558-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076558-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076558-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076558-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076558-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076558-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076558-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076558-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076558-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076558-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076558-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076558-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076558-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076558-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076558-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076558-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076558-002AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-3368CIPROFLOXACIN TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]5Legacy NDC20250206_8bca6829-da32-42fe-b2b7-4bdfb9a89e43.zip

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.c08b37c3-5f01-47ed-9508-02813bbd008b2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINREMEDYREPACK INC.44b6cefc-7638-4437-95e7-8f239f66a9d42026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.3b9b15f7-354b-4049-982b-f6f31751a8852026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINNorthwind Health Company, LLCf67d727f-b9ca-aec0-e053-2995a90aab692026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.fa32aafd-e3f5-4be6-9413-c7663c1c2cec2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.5723eaf9-8659-4730-b792-4e4c33690ccb2025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.d275175c-691a-4d09-bbb7-50ee819e67272025-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CIPROFLOXACINCIPROFLOXACINDirectRxd23e359d-6d12-38f6-e053-2a95a90a0a882025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINDirectRxd358eb18-f4d0-e9ba-e053-2a95a90a435d2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINGolden State Medical Supply, Inc.2e1addcf-6d5b-46c8-812b-558fd847f0052025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINHikma Pharmaceuticals USA Inc.3b3d22dc-df09-4910-8c9b-1204eeedbd682024-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINBryant Ranch Prepack4f600112-168a-4a58-9914-7c01f71894da2024-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINBryant Ranch Prepacka57066d7-dc2c-d2d0-b003-d9143fcca1c52024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558
CiprofloxacinCIPROFLOXACINAsclemed USA, Inc.1bb1d26e-fad0-4338-8948-3f095d5817a62022-03-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076558
application number: ANDA076558

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-3368-05515433680010 BLISTER PACK in 1 BAG (55154-3368-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2004-06-090000-00-00NoNoCurrent