Ciprofloxacin Hydrochloride

Product NDC
33261-910
11-digit product format
332610910
Labeler code
33261
Product ID
33261-910_1feb09ed-35ba-4e97-8198-bfc979767f4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA019992
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-04-03
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 productproduct33261-910IInactivated by FDA2026-08-03
excluded packagepackage33261-91033261-910-01IInactivated by FDA2026-08-03

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 packagepackage33261-910-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33261-910-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33261-910-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33261-910-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33261-910-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33261-910-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33261-910-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33261-910-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33261-910-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33261-910-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33261-910-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33261-910-01557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage33261-910-018af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage33261-910-01834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage33261-910-011332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage33261-910-01fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage33261-910-0186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage33261-910-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage33261-910-018dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage33261-910-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage33261-910-019bebd1f3094a…5416666fcb17…

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…

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
33261-910-012020-01-31C16284748780-19d75b9d0-0b11-f424-e053-dadaa90a57ceCiprofloxacin Hydrochloride Ophthalmic Solution 0.3% as base Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-910-01Ciprofloxacin Hydrochloride2.5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS2.51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-910-01ML - Milliliter33261-9106b0acfb8-5a47-4a1a-9a21-325b41e5fb0012018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-910CIPROFLOXACIN HYDROCHLORIDE SOLUTION/ DROPS [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180822_d88a73c8-24d6-433e-a2c3-69b91e7be96a.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
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 SolutionPSNd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin 3 MG/ML Ophthalmic SolutionSCDd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin 0.3 % Ophthalmic SolutionSYd88a73c8-24d6-433e-a2c3-69b91e7be96a1
309307ciprofloxacin 3 MG/ML (as ciprofloxacin hydrochloride 3.5 MG/ML) Ophthalmic SolutionSYd88a73c8-24d6-433e-a2c3-69b91e7be96a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
33261-910-01332610910012.5 mL in 1 BOTTLE, PLASTIC2.5 mlHistorical