ciprofloxacin

Product NDC
55545-1011
11-digit product format
555451011
Labeler code
55545
Product ID
55545-1011_3ed875b7-75eb-4ba1-9a36-80f13fb73454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
FDC Limited
Application
ANDA077568
Marketing category
ANDA
Marketing start
2018-11-01
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

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
A077568-001CIPROFLOXACIN HYDROCHLORIDECIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077568-001AT

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-3087673890dc5c…
2021-03-12 10:30 UTC2021-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303f01610625f2…
2019-09-15 20:21 UTC2019-09A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30b00525d2431f…
2019-07-19 19:46 UTC2019-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303f0d92c62455…
2023-05-13 08:27 UTC2023-05A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30053a50430f4f…
2023-01-26 05:58 UTC2023-01A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077568-001CIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICAT2008-06-30e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077568-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077568-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077568-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077568-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077568-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077568-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077568-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077568-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077568-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077568-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077568-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077568-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077568-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077568-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077568-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077568-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077568-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077568-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077568-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077568-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A077568-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A077568-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A077568-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A077568-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A077568-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A077568-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A077568-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077568-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A077568-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A077568-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A077568-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A077568-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A077568-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A077568-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A077568-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A077568-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A077568-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A077568-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A077568-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077568-001AT1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55545-1011-1ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-1ciprofloxacin2.5 mL in 1 BOTTLE, PLASTICSOLUTION2.51
55545-1011-2ciprofloxacin1 in 1 CARTONSOLUTION11
55545-1011-2ciprofloxacin5 mL in 1 BOTTLE, PLASTICSOLUTION51
55545-1011-3ciprofloxacin10 mL in 1 BOTTLE, PLASTICSOLUTION101
55545-1011-3ciprofloxacin1 in 1 CARTONSOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55545-1011CIPROFLOXACIN SOLUTION [FDC LIMITED]1Legacy NDC, 6 package rows20181101_0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc.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 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ciprofloxacinCIPROFLOXACINHAWAII REPACK, INC4caf49d9-b06f-4d57-aac3-cc64ae12cc952026-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINRedpharm Drug541bd97e-b2ff-09a8-e063-6394a90aee962026-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINSportpharm LLC190395a8-c05f-4e31-9a89-7af6428ebbb92026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINPreferred Pharmaceuticals, Inc.85c48ebc-d94a-4254-86df-d2c1aff09b372026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINAdvanced Rx of Tennessee, LLC30cb2b42-aa4b-8cec-e063-6394a90aa6152025-03-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINA-S Medication Solutions766251ac-2040-4a79-9ca5-a1e5f1e01cb52024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7def5a45-6725-0521-e053-2991aa0a0bda2024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINNuCare Pharmaceuticals,Inc.7d533171-0879-3854-e053-2a91aa0a3b462024-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINLeading Pharma, LLC545527e7-05c7-4dbf-ab32-b3fa463d55b02024-05-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINAsclemed USA, Inc.86c2ba30-9372-4e70-88a2-e6e1da07fa922023-09-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568
ciprofloxacinCIPROFLOXACINProficient Rx LP05b2836d-cd3d-4d7f-970c-66ec2d7886672022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077568
application number: ANDA077568

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSN0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCD0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1
309307ciprofloxacin 0.3 % Ophthalmic SolutionSY0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSY0e9e58a0-6572-43b0-8b2e-e56e6ae8f1bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55545-1011-1555451011011 in 1 CARTONHistorical
55545-1011-2555451011021 in 1 CARTONHistorical
55545-1011-35554510110310 mL in 1 BOTTLE, PLASTIC10 mlHistorical