CIPROFLOXACIN

Product NDC
61919-735
11-digit product format
619190735
Labeler code
61919
Product ID
61919-735_3e0eabed-451b-123c-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CIPROFLOXACIN
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076639
Marketing category
ANDA
Marketing start
2016-09-12
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 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 productproduct61919-735IInactivated by FDA2026-10-05
excluded packagepackage61919-73561919-735-90IInactivated 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 1 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-735-90IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-735-90IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-735-90IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-735-90IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-735-90IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-735-90IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-735-90IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-735-90IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-735-90IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-735-90IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-735-90IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-735-90IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-735-90IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-735-90IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-735-90IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-735-90IInactivated 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 packagepackage61919-735-90IInactivated 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 packagepackage61919-735-90IInactivated 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 packagepackage61919-735-90IInactivated 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 packagepackage61919-735-90IInactivated 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 packagepackage61919-735-90IInactivated 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 packagepackage61919-735-90EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076639-001CIPROFLOXACIN HYDROCHLORIDEEQ 250MG BASETABLET / ORALAB2004-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A076639-002CIPROFLOXACIN HYDROCHLORIDEEQ 500MG BASETABLET / ORALAB2004-09-1084e616aacf4f…
2026-09-14 22:38:342026-08A076639-003CIPROFLOXACIN HYDROCHLORIDEEQ 750MG BASETABLET / ORALAB2004-09-1084e616aacf4f…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076639-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A076639-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A076639-003AB184e616aacf4f…
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…

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-735-902020-01-31C16284748780-19d75b9d0-3517-f424-e053-dadaa90a57ceCIPROFLOXACIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-735-90CIPROFLOXACIN90 in 1 BOTTLETABLET902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-735CIPROFLOXACIN TABLET [DIRECT RX]2Legacy NDC, 1 package rows20161013_3c4fc96d-9017-5802-e054-00144ff88e88.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
ciprofloxacinCIPROFLOXACINCardinal Health 107, LLC922e9f5c-cc59-4d9e-bf42-a4b900d077ed2026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076639
application number: ANDA076639
ciprofloxacinCIPROFLOXACINNorthwind Health Company, LLC4deea61e-f3ca-b35d-e063-6294a90a9d412026-07-21Boxed 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
197512ciprofloxacin 750 MG Oral TabletPSN3c4fc96d-9017-5802-e054-00144ff88e882
197512ciprofloxacin 750 MG Oral TabletSCD3c4fc96d-9017-5802-e054-00144ff88e882
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY3c4fc96d-9017-5802-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-735-906191907359090 in 1 BOTTLEHistorical