ciprofloxacin

Product NDC
75921-412
11-digit product format
759210412
Labeler code
75921
Product ID
75921-412_17081ef1-c58a-47fc-9683-d9b6776234f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Life Line Home Care Services, Inc.
Application
ANDA076639
Marketing category
ANDA
Marketing start
2012-02-06
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75921-412IInactivated by FDA2026-08-17
excluded packagepackage75921-41275921-412-20IInactivated by FDA2026-08-17

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 · 44 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 packagepackage75921-412-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage75921-412-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage75921-412-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage75921-412-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage75921-412-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage75921-412-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage75921-412-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage75921-412-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage75921-412-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage75921-412-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage75921-412-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage75921-412-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage75921-412-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage75921-412-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage75921-412-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage75921-412-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage75921-412-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage75921-412-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage75921-412-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage75921-412-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage75921-412-209bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage75921-412-20110d247fa046…a55b01930146…

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
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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-10caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076639-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076639-003AB1caaa826d4ba7…
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…

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
75921-412-202019-11-13C16284748780-197449f38-b84c-f6ea-e053-dbdaa90aa703Ciprofloxacin Tablets 250 mg, 500 mg and 750 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75921-412-20ciprofloxacin20 in 1 BOTTLETABLET201

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75921-412CIPROFLOXACIN TABLET [LIFE LINE HOME CARE SERVICES, INC.]1Legacy NDC, 1 package rows20120206_b08afc40-cfb0-4808-aa0b-b8a2b6008dd8.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 TabletPSNb08afc40-cfb0-4808-aa0b-b8a2b6008dd81
309309ciprofloxacin 500 MG Oral TabletSCDb08afc40-cfb0-4808-aa0b-b8a2b6008dd81
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYb08afc40-cfb0-4808-aa0b-b8a2b6008dd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
75921-412-207592104122020 in 1 BOTTLEHistorical