Ciprofloxacin

Product NDC
50090-1685
Requested package NDC
50090-1685-3
11-digit product format
500901685
Labeler code
50090
Product ID
50090-1685_b4d6a8fb-8639-4a47-9303-9791d2526b5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076794
Marketing category
ANDA
Marketing start
2006-11-01
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
2022-12-31
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 packagepackage50090-168550090-1685-3IInactivated by FDA2026-08-10

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A076794-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09
A076794-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09
A076794-004CIPROFLOXACIN 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
A076794-002AB
A076794-003AB
A076794-004AB

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 · 153 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-001CIPROFLOXACIN HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2005-02-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-001CIPROFLOXACIN HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2005-02-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-003CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-004CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076794-001CIPROFLOXACIN HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2005-02-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076794-002CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-091e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 147 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076794-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076794-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076794-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076794-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076794-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076794-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076794-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076794-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076794-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076794-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076794-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076794-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076794-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076794-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076794-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076794-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076794-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076794-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076794-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076794-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076794-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076794-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076794-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076794-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076794-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076794-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076794-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076794-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076794-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076794-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076794-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076794-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076794-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076794-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076794-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076794-002AB18072bd15b7f6…

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1685-0Ciprofloxacin6 in 1 BOTTLETABLET, FILM COATED612
50090-1685-1Ciprofloxacin14 in 1 BOTTLETABLET, FILM COATED1412
50090-1685-2Ciprofloxacin10 in 1 BOTTLETABLET, FILM COATED1012
50090-1685-3Ciprofloxacin3 in 1 BOTTLETABLET, FILM COATED312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1685-3EA - Each50090-16853d787993-0f2f-45c0-a95f-42e599aee37312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1685CIPROFLOXACIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]12Legacy NDC, 4 package rows20211112_d5e8cc10-aa34-436c-bf09-16f0e8fafde2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CiprofloxacinCIPROFLOXACINTeva Pharmaceuticals USA, Inc.3e4402d4-e0d3-9846-3e81-ed46f34137fe2024-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076794
application number: ANDA076794
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.b0136d72-0869-2da0-e053-2995a90af70a2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076794
application number: ANDA076794
CiprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.b064286b-fedc-be68-e053-2995a90aae522024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076794
application number: ANDA076794

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSNd5e8cc10-aa34-436c-bf09-16f0e8fafde212
197511ciprofloxacin 250 MG Oral TabletSCDd5e8cc10-aa34-436c-bf09-16f0e8fafde212
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSYd5e8cc10-aa34-436c-bf09-16f0e8fafde212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1685-3500901685033 TABLET, FILM COATED in 1 BOTTLE (50090-1685-3) 2021-09-100000-00-00NoNoCurrent