ciprofloxacin

Product NDC
51655-118
11-digit product format
516550118
Labeler code
51655
Product ID
51655-118_b8fa8de7-dac7-4d6c-a12c-96359843471f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Pharmaceuticals
Application
ANDA076639
Marketing category
ANDA
Marketing start
2014-06-01
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51655-118IInactivated by FDA2026-08-10
excluded packagepackage51655-11851655-118-20IInactivated by FDA2026-08-10
excluded packagepackage51655-11851655-118-25IInactivated by FDA2026-08-10
excluded packagepackage51655-11851655-118-52IInactivated by FDA2026-08-10
excluded packagepackage51655-11851655-118-53IInactivated by FDA2026-08-10
excluded packagepackage51655-11851655-118-84IInactivated by FDA2026-08-10
excluded packagepackage51655-11851655-118-87IInactivated 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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-118-53IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-118-20IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage51655-118-84IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-118-53IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-118-20IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage51655-118-84IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-118-53IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-118-20IInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage51655-118-84IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-118-53IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-118-20IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage51655-118-84IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-118-53IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-118-20IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage51655-118-84IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-118-53IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-118-20IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage51655-118-84IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-118-53EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-118-84EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage51655-118-20EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A076639-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10
A076639-002CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10
A076639-003CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076639-001AB
A076639-002AB
A076639-003AB

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 · 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 UTC2026-02A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-108072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076639-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076639-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076639-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076639-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076639-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076639-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076639-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076639-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076639-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076639-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076639-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076639-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076639-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076639-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076639-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076639-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076639-001AB18072bd15b7f6…

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, Related label table
NDCEffectiveRelated label
51655-118-202026-01-29These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-252026-01-29These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-522026-01-29These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-532026-01-29These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-842026-01-29These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-872026-01-29These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-202023-07-03These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-532023-07-03These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-842023-07-03These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-202020-01-31These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-532020-01-31These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987
51655-118-842020-01-31These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and effectively. See full prescribing information for CIPROFLOXACIN TABLETS. CIPROFLOXACIN tablet, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-118-20ciprofloxacin20 in 1 BOTTLE, DISPENSINGTABLET206
51655-118-25ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET606
51655-118-52ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET306
51655-118-53ciprofloxacin10 in 1 BOTTLE, DISPENSINGTABLET106
51655-118-84ciprofloxacin14 in 1 BOTTLE, DISPENSINGTABLET146
51655-118-87ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET66

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [NORTHWIND PHARMACEUTICALS]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [NORTHWIND PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-118CIPROFLOXACIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]6Legacy NDC, 6 package rows20240713_3f021061-55f3-4108-a386-0647b0c5f01a.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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINNorthwind Health Company, LLC4deea61e-f3ca-b35d-e063-6294a90a9d412026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINCardinal Health 107, LLC922e9f5c-cc59-4d9e-bf42-a4b900d077ed2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINMajor Pharmaceuticalsf818ed31-c746-4171-afdf-57a75434e5f12026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINQPharma, Inc.4149d980-a6cd-c06d-e063-6394a90a47a12025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINRising Pharma Holdings, Inc.ef468722-68cd-440b-afd7-2285029db41f2025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.2491e6a9-3415-43b9-b31b-67331f52806a2025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.e81341c6-0e25-4860-adda-2d3cebe88d622025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPD-Rx Pharmaceuticals, Inc.178dc379-e2b8-4b47-9f0c-3fc7fb435c362025-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINA-S Medication Solutionsc12b316f-811c-48b6-a320-d314991aa74f2025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINBryant Ranch Prepack69df48cc-76b6-428e-891a-c25e07d785f82025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINBryant Ranch Prepacka5ecc693-b8fd-4a7a-8040-e56f801c93532025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINCoupler LLC2fff7a38-2c4e-d343-e063-6294a90aca3c2025-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINUmasuto, LLC0c355077-7361-41d0-9e82-eb31beaf5daa2025-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.44e5582d-fff1-0ec9-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals, Inc.46dedf2c-26de-0f46-e054-00144ff88e882024-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.641729a3-6dd3-3a2f-e053-2991aa0a015e2024-06-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.5bab9397-b9f3-d309-e053-2991aa0a66122024-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINA-S Medication Solutions6971a958-08f0-4712-bf5f-47fe4f76b8632023-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPharmPak, Inc.e2902d14-16bb-46a9-a45a-4f1f9b0ecf4a2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINPharmPak, Inc.6a70db6c-ae68-49e5-8a4a-b5cd1d4840bd2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN3f021061-55f3-4108-a386-0647b0c5f01a6
309309ciprofloxacin 500 MG Oral TabletSCD3f021061-55f3-4108-a386-0647b0c5f01a6
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3f021061-55f3-4108-a386-0647b0c5f01a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51655-118-205165501182020 in 1 BOTTLE, DISPENSINGHistorical
51655-118-255165501182560 in 1 BOTTLE, PLASTICHistorical
51655-118-525165501185230 in 1 BOTTLE, PLASTICHistorical
51655-118-535165501185310 in 1 BOTTLE, DISPENSINGHistorical
51655-118-845165501188414 in 1 BOTTLE, DISPENSINGHistorical
51655-118-87516550118876 in 1 BOTTLE, PLASTICHistorical