FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
52959-730
11-digit product format
529590730
Labeler code
52959
Product ID
52959-730_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
500 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
52959-730-002019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-042019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-062019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-102019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-142019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-152019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-202019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-212019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-282019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-302019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-730-602019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-730-00Ciprofloxacin100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
52959-730-04Ciprofloxacin4 in 1 BOTTLE, PLASTICTABLET, FILM COATED42
52959-730-06Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62
52959-730-10Ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102
52959-730-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED142
52959-730-15Ciprofloxacin15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
52959-730-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
52959-730-21Ciprofloxacin21 in 1 BOTTLE, PLASTICTABLET, FILM COATED212
52959-730-28Ciprofloxacin28 in 1 BOTTLE, PLASTICTABLET, FILM COATED282
52959-730-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
52959-730-60Ciprofloxacin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-730-00EA - Each52959-73015c84af2-9893-4428-aa67-a739c2aacdc912012-07-24
52959-730-04EA - Each52959-730936a3ccf-f367-48d8-80a5-7089fdd2608512012-07-24
52959-730-06EA - Each52959-730819cafab-8cf0-4012-9979-2bfe0eec0c0b12012-07-24
52959-730-10EA - Each52959-73067afb9bf-fd8e-46a9-8dea-e44c4497c1d712012-07-24
52959-730-14EA - Each52959-730fcbd1635-f4f6-4efb-9101-ad0eaff7267a12012-07-24
52959-730-15EA - Each52959-7303a5debec-b505-4e42-b981-ac750464bb2712012-07-24
52959-730-20EA - Each52959-730410532f6-b6a8-4447-a547-08b5ad4c1bfb12012-07-24
52959-730-21EA - Each52959-73006ec8586-11e5-410a-9666-a5b8092aafe012012-07-24
52959-730-28EA - Each52959-7304a15d5b3-361f-42b4-91d9-9b3e59f249c712012-07-24
52959-730-30EA - Each52959-730676220ec-561f-44a9-81d8-8f3488d1ffc012012-07-24
52959-730-60EA - Each52959-73050958456-1045-43a2-bf28-98a1bd78955812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
crospovidoneINACTIVE INGREDIENT68401960MKCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
polyvinyl alcoholINACTIVE INGREDIENT532B59J990CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-730CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 11 package rows20111201_99a81fda-81dc-40b3-b55a-165b6e4ca4ee.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-730-0052959073000100 in 1 BOTTLE, PLASTICHistorical
52959-730-04529590730044 in 1 BOTTLE, PLASTICHistorical
52959-730-06529590730066 in 1 BOTTLE, PLASTICHistorical
52959-730-105295907301010 in 1 BOTTLE, PLASTICHistorical
52959-730-145295907301414 in 1 BOTTLE, PLASTICHistorical
52959-730-155295907301515 in 1 BOTTLE, PLASTICHistorical
52959-730-205295907302020 in 1 BOTTLE, PLASTICHistorical
52959-730-215295907302121 in 1 BOTTLE, PLASTICHistorical
52959-730-285295907302828 in 1 BOTTLE, PLASTICHistorical
52959-730-305295907303030 in 1 BOTTLE, PLASTICHistorical
52959-730-605295907306060 in 1 BOTTLE, PLASTICHistorical