Ciprofloxacin Hydrochloride

Product NDC
70518-1170
11-digit product format
705181170
Labeler code
70518
Product ID
70518-1170_36e8be23-f959-0d00-e063-6294a90ae770
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
REMEDYREPACK INC.
Application
NDA019992
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-05-15
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
3 mg/mL
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-117070518-1170-1DDiscontinued by firm2026-08-07

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N019992-001CILOXANCIPROFLOXACIN HYDROCHLORIDEEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N019992-001AT

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-3187673890dc5c…
2021-03-12 10:30 UTC2021-03N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-315aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-318869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-313f01610625f2…
2019-09-15 20:21 UTC2019-09N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31b00525d2431f…
2019-07-19 19:46 UTC2019-07N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-316a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-311c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-319b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-313f0d92c62455…
2023-05-13 08:27 UTC2023-05N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31053a50430f4f…
2023-01-26 05:58 UTC2023-01N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-313bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-313a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019992-001CILOXANEQ 0.3% BASESOLUTION/DROPS / OPHTHALMICATRLD, RS1990-12-31cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N019992-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019992-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N019992-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019992-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019992-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N019992-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N019992-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N019992-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N019992-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N019992-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N019992-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N019992-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N019992-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N019992-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N019992-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N019992-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N019992-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N019992-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N019992-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N019992-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N019992-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N019992-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N019992-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N019992-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N019992-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N019992-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N019992-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N019992-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N019992-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N019992-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N019992-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N019992-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N019992-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N019992-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N019992-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N019992-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N019992-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N019992-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N019992-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N019992-001AT1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4BA73M5E37Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2cec2cc-729b-4baa-8df1-c3f70847a483Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1170-0Ciprofloxacin Hydrochloride1 in 1 CARTONSOLUTION/ DROPS110
70518-1170-0Ciprofloxacin Hydrochloride5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1170CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 2 package rows20250508_a2cec2cc-729b-4baa-8df1-c3f70847a483.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
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDERedpharm Drug1ac4540c-d0f7-70bc-e063-6394a90a0f7a2026-05-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEPreferred Pharmaceuticals Inc.78641acd-eedf-4b68-bb18-da0874415f592026-03-27Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEREMEDYREPACK INC.a2cec2cc-729b-4baa-8df1-c3f70847a4832025-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
ndc (product): 70518-1170
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEAsclemed USA, Inc.509b932e-9229-42c0-8a4c-f3257ffdca492025-03-29Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.5cf0f572-48fc-6a3a-e053-2991aa0a84372025-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.6301febb-01aa-1af5-e053-2991aa0aa3092025-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutionsec3a3dcf-b9c9-432e-adfe-4b30cade89312024-11-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEA-S Medication Solutions694b79f6-599f-4a71-bf02-d0d09767a7352024-10-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDENuCare Pharmaceuticals,Inc.54c73290-bd89-3453-e054-00144ff88e882024-07-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDEProficient Rx LPe04dfddd-6177-4c2e-8f42-acd65848e6e22022-12-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992
Ciprofloxacin HydrochlorideCIPROFLOXACIN HYDROCHLORIDESandoz Incab52b14d-345b-47ff-a832-465caddd38012019-07-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 019992
application number: NDA019992

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309307ciprofloxacin HCl 0.3 % Ophthalmic SolutionPSNa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYa2cec2cc-729b-4baa-8df1-c3f70847a48310
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYa2cec2cc-729b-4baa-8df1-c3f70847a48310

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-1170-0705181170001 BOTTLE, PLASTIC in 1 CARTON (70518-1170-0) / 5 mL in 1 BOTTLE, PLASTIC2018-05-15NoNoCurrent