Ciprofloxacin

Product NDC
63304-709
11-digit product format
633040709
Labeler code
63304
Product ID
63304-709_aa0b6a4a-f8ff-4d09-8813-2d58192c08c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA075747
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63304-709IInactivated by FDA2026-10-05
excluded packagepackage63304-70963304-709-01IInactivated by FDA2026-10-05
excluded packagepackage63304-70963304-709-05IInactivated by FDA2026-10-05
excluded packagepackage63304-70963304-709-14IInactivated by FDA2026-10-05
excluded packagepackage63304-70963304-709-80IInactivated by FDA2026-10-05

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 2 · 110 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 packagepackage63304-709-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-709-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-709-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63304-709-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-709-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-709-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-709-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63304-709-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-709-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-709-802ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-709-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63304-709-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-709-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-709-80a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-709-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63304-709-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-709-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-709-80cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-709-05cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63304-709-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-709-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-709-80cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-709-05cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63304-709-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-709-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-709-80302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-709-05302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63304-709-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-709-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-709-80ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-709-05ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63304-709-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-709-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-709-800efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-709-050efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63304-709-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-709-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-709-80ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-709-05ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63304-709-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-709-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-709-80367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-709-05367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63304-709-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-709-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-709-80557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-709-05557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63304-709-14557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075747-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09
A075747-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09
A075747-003CIPROFLOXACIN 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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-0984e616aacf4f…
2026-09-14 22:38:342026-08A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-0984e616aacf4f…
2026-08-18 06:07:402026-07A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075747-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORAL2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075747-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORAL2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075747-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORAL2004-06-09301d65b070ca…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-709-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1003
63304-709-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED5003
63304-709-14Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED143
63304-709-80Ciprofloxacin100 in 1 BLISTER PACKTABLET, FILM COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-709-01EA - Each63304-70927840e42-93f5-4f31-9376-9eb3dda9b8f412013-02-13

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-709CIPROFLOXACIN TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]3Legacy NDC, 4 package rows20130930_563e576e-6966-4f8d-91bb-0a1a951de324.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN563e576e-6966-4f8d-91bb-0a1a951de3243
309309ciprofloxacin 500 MG Oral TabletPSN563e576e-6966-4f8d-91bb-0a1a951de3243
197512ciprofloxacin 750 MG Oral TabletPSN563e576e-6966-4f8d-91bb-0a1a951de3243
197511ciprofloxacin 250 MG Oral TabletSCD563e576e-6966-4f8d-91bb-0a1a951de3243
309309ciprofloxacin 500 MG Oral TabletSCD563e576e-6966-4f8d-91bb-0a1a951de3243
197512ciprofloxacin 750 MG Oral TabletSCD563e576e-6966-4f8d-91bb-0a1a951de3243
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY563e576e-6966-4f8d-91bb-0a1a951de3243
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY563e576e-6966-4f8d-91bb-0a1a951de3243
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY563e576e-6966-4f8d-91bb-0a1a951de3243

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-709-0163304070901100 in 1 BOTTLEHistorical
63304-709-0563304070905500 in 1 BOTTLEHistorical
63304-709-146330407091414 in 1 BOTTLEHistorical
63304-709-8063304070980100 in 1 BLISTER PACKHistorical