FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
52959-734
11-digit product format
529590734
Labeler code
52959
Product ID
52959-734_9adbd7e3-4ea3-4ef7-8112-a6a0c31b4b6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA076794
Marketing category
ANDA
Marketing start
2004-06-09
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
750 mg/1
Pharmacologic classes
Quinolone Antimicrobial [EPC],Quinolones [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ea50b939-d92a-4100-84f5-1c1089663837Product name220240705
90aab9f8-63f3-478d-8db8-951525a18ab1Product name120180814
200e1d3d-46da-4371-beed-747da3cb3ff8Product name120180702
9e453f34-aacb-44d5-a119-c0e3dc1fca2aProduct name120160622
01eecbfe-0b50-413b-8898-6905c89b6568Product name120151228
a3304bb6-ef4e-06df-d604-35f7e883ed6cProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
de5ea793-ffd9-0308-b0ca-00d9967be4eeProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-734-502020-01-31C16284748780-19d75b9d0-f322-f424-e053-dadaa90a57ce5f4e80a1-0225-63dd-e053-2991aa0aa7fb
52959-734-142019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-734-202019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-734-302019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-734-602019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-734-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED142
52959-734-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
52959-734-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
52959-734-60Ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
52959-734-50CIPROFLOXACIN50 in 1 CONTAINERTABLET, FILM COATED501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-734CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 package rows20111201_99a81fda-81dc-40b3-b55a-165b6e4ca4ee.zip
52959-734CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H. J. HARKINS COMPANY INC.]1Legacy NDC, 1 package rows20171206_5f4e80a1-0225-63dd-e053-2991aa0aa7fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
309309ciprofloxacin 500 MG Oral TabletPSN99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin 750 MG Oral TabletPSN99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197511ciprofloxacin 250 MG Oral TabletSCD99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
309309ciprofloxacin 500 MG Oral TabletSCD99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin 750 MG Oral TabletSCD99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY99a81fda-81dc-40b3-b55a-165b6e4ca4ee2
197512ciprofloxacin 750 MG Oral TabletPSN5f4e80a1-0225-63dd-e053-2991aa0aa7fb1
197512ciprofloxacin 750 MG Oral TabletSCD5f4e80a1-0225-63dd-e053-2991aa0aa7fb1
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY5f4e80a1-0225-63dd-e053-2991aa0aa7fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-734-145295907341414 in 1 BOTTLE, PLASTICHistorical
52959-734-205295907342020 in 1 BOTTLE, PLASTICHistorical
52959-734-305295907343030 in 1 BOTTLE, PLASTICHistorical
52959-734-505295907345050 in 1 CONTAINERHistorical
52959-734-605295907346060 in 1 BOTTLE, PLASTICHistorical