Ciprofloxacin

Product NDC
50090-5621
Requested package NDC
50090-5621-0
11-digit product format
500905621
Labeler code
50090
Product ID
50090-5621_044d3de8-7717-47c8-9d16-a4675e0d6de4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075593
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
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 packagepackage50090-562150090-5621-0DDiscontinued by firm2026-08-17

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 · 11 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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075593-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09
A075593-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09
A075593-004CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG 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
A075593-001AB
A075593-003AB
A075593-004AB

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 · 156 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-002CIPROFLOXACIN HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-004CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-06-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075593-001CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075593-002CIPROFLOXACIN HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2004-06-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075593-003CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-06-09301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A075593-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075593-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075593-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075593-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075593-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075593-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075593-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075593-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075593-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075593-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075593-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075593-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075593-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075593-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075593-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-003AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075593-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075593-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075593-003AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075593-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075593-001AB11e350fbaab3a…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5621-02023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-12023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-32023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-42023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-52023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-72023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-82023-02-07These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-02023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-12023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-32023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-42023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-52023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-72023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987
50090-5621-82023-01-30These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablets, for oral use Initial U.S. Approval: 1987

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5621-0EA - Each50090-56219518d233-e8e3-42de-a6ed-cc3d2aa9ff1012022-10-06
50090-5621-1EA - Each50090-56219fa741f8-c298-4df8-ad89-cee729bf51c612022-12-07
50090-5621-3EA - Each50090-56215bac4c3f-209f-4f00-ad65-ff6faf661a4212022-12-07
50090-5621-4EA - Each50090-5621f298e009-1600-4f85-b57a-406a652f452412022-12-07
50090-5621-5EA - Each50090-5621a88af5d2-75f6-4862-98fa-d17f198217f712022-12-07
50090-5621-7EA - Each50090-5621e308d0dc-488c-4c8a-a45c-dc7d5add045312022-12-07
50090-5621-8EA - Each50090-562134a1bffd-6157-4d44-9893-5a4d08879a3c12022-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5621-05009056210020 TABLET, FILM COATED in 1 BOTTLE (50090-5621-0) 2021-08-260000-00-00NoNoCurrent