Ciprofloxacin

Product NDC
45865-772
11-digit product format
458650772
Labeler code
45865
Product ID
45865-772_9ab40b20-86fb-6593-e053-2a95a90a1994
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC; TOPICAL
Labeler
Medsource Pharmaceuticals
Application
ANDA076673
Marketing category
ANDA
Marketing start
2005-01-21
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
2020-12-31
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 productproduct45865-772IInactivated by FDA2026-10-05
excluded packagepackage45865-77245865-772-01IInactivated 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 · 18 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 packagepackage45865-772-01IInactivated 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 packagepackage45865-772-01IInactivated 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 packagepackage45865-772-01IInactivated 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 packagepackage45865-772-01IInactivated 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 packagepackage45865-772-01IInactivated 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 packagepackage45865-772-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-772-01UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-772-01UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-772-01UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A076673-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076673-001AT

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-2184e616aacf4f…
2026-08-18 06:07:402026-07A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076673-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2005-01-21f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A076673-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A076673-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076673-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076673-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076673-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076673-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076673-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076673-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076673-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076673-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076673-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076673-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076673-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076673-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076673-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076673-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076673-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076673-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076673-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076673-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076673-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076673-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076673-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A076673-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076673-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076673-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076673-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A076673-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076673-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076673-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076673-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076673-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076673-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076673-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076673-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076673-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076673-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076673-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076673-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076673-001AT1f41ea6bd6efb…

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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product 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
45865-772-012025-01-30C16284748780-12cef2736-905d-d83d-e063-dadaa90ab31fCiprofloxacin Ophthalmic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-772-01Ciprofloxacin10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS102
45865-772-01Ciprofloxacin1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-772CIPROFLOXACIN SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20191228_205dc274-ff95-05ac-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN205dc274-ff95-05ac-e054-00144ff88e882
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD205dc274-ff95-05ac-e054-00144ff88e882
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY205dc274-ff95-05ac-e054-00144ff88e882
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY205dc274-ff95-05ac-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-772-01458650772011 BOTTLE, DROPPER in 1 CARTON (45865-772-01) > 10 mL in 1 BOTTLE, DROPPER2015-09-220000-00-00NoNoCurrent