Ciprofloxacin

Product NDC
67296-1389
Requested package NDC
67296-1389-1
11-digit product format
672961389
Labeler code
67296
Product ID
67296-1389_d61b7442-a7ff-62c4-e053-2a95a90ad9b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA077859
Marketing category
ANDA
Marketing start
2007-04-26
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67296-138967296-1389-1IInactivated by FDA2026-10-16

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A077859-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26
A077859-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26
A077859-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077859-001AB
A077859-002AB
A077859-003AB

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 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26c2088c7a36db…
2026-10-15 13:18:302026-09A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26c2088c7a36db…
2026-10-15 13:18:302026-09A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26c2088c7a36db…
2026-09-14 22:38:342026-08A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2684e616aacf4f…
2026-09-14 22:38:342026-08A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2684e616aacf4f…
2026-08-18 06:07:402026-07A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2007-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2007-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2007-04-2679d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A077859-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077859-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A077859-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A077859-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A077859-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A077859-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A077859-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077859-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077859-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077859-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077859-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077859-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077859-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077859-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077859-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077859-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077859-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077859-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077859-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077859-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077859-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077859-001AB179d66fd596c7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1389-12024-01-30C16284748780-11030e365-1a01-111a-e063-dadaa90a10e2505d0a1e-6cfd-6b9d-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1389-1Ciprofloxacin28 in 1 BOTTLETABLET, FILM COATED283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1389CIPROFLOXACIN TABLET, FILM COATED [REDPHARM DRUG, INC.]3Legacy NDC, 1 package rows20220122_505d0a1e-6cfd-6b9d-e054-00144ff88e88.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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.3c611c8c-deed-4904-93f7-f75a2147fbf72025-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited7041828f-d4ec-4813-bcac-cb335c6c312a2025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAurobindo Pharma Limited2b3b6a9f-259c-4736-b88f-f49d1eb642862025-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionscc768d3e-a7cc-46a2-ae6d-0f5eb2f054062025-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.1cb05412-372e-4b49-92e1-532caa05f38f2025-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPec337816-4f48-4d04-b91d-60f9f5f634da2024-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEProficient Rx LP9ee1f252-a64e-4b72-a6f7-60298e8272222022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859
CiprofloxacinCIPROFLOXACIN HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC4e74496f-4dca-4471-be32-c0a14bc627502018-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077859
application number: ANDA077859

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197512ciprofloxacin 750 MG Oral TabletPSN505d0a1e-6cfd-6b9d-e054-00144ff88e883
197512ciprofloxacin 750 MG Oral TabletSCD505d0a1e-6cfd-6b9d-e054-00144ff88e883
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY505d0a1e-6cfd-6b9d-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1389-16729613890128 TABLET, FILM COATED in 1 BOTTLE (67296-1389-1) 2007-04-260000-00-00NoNoCurrent