Ciprofloxacin

Product NDC
33261-614
11-digit product format
332610614
Labeler code
33261
Product ID
33261-614_dc08c947-6dde-4f8b-ac36-46a390f99a7e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA076555
Marketing category
ANDA
Marketing start
2018-01-18
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct33261-614IInactivated by FDA2026-08-17
excluded packagepackage33261-61433261-614-01IInactivated 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 · 42 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 packagepackage33261-614-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-614-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-614-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-614-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-614-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-614-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-614-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-614-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-614-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-614-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-614-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-614-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-614-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-614-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-614-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-614-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-614-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-614-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-614-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-614-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-614-019bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076555-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-113f01610625f2…
2019-09-15 20:21 UTC2019-09A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMIC2008-12-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076555-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-12-11e64feba35796…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076555-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076555-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076555-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076555-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076555-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076555-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076555-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A076555-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076555-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076555-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076555-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A076555-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076555-001AT1ea99ee380514…
2023-01-26 05:58 UTC2023-01A076555-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076555-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076555-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076555-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076555-001AT1cb3db0bc1861…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-614-012020-01-31C16284748780-19d75b9d0-631f-f424-e053-dadaa90a57ceCiprofloxacin Ophthalmic Solution, USP 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-614-01Ciprofloxacin5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-614-01ML - Milliliter33261-614fb14915d-5d46-4487-ab4f-71c362b1371412018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-614CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180821_b7910edd-2037-40a8-b24b-6fd4752f9ef0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNb7910edd-2037-40a8-b24b-6fd4752f9ef01
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDb7910edd-2037-40a8-b24b-6fd4752f9ef01
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYb7910edd-2037-40a8-b24b-6fd4752f9ef01
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYb7910edd-2037-40a8-b24b-6fd4752f9ef01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-614-01332610614015 mL in 1 BOTTLE, DROPPER5 mlHistorical