FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
52959-739
11-digit product format
529590739
Labeler code
52959
Product ID
52959-739_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
250 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
52959-739-062019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-739-142019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-739-202019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP
52959-739-302019-11-13C16284748780-197449f38-bd44-f6ea-e053-dbdaa90aa703CIPROFLOXACIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-739-06Ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62
52959-739-14Ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET, FILM COATED142
52959-739-20Ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED202
52959-739-30Ciprofloxacin30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-739-06EA - Each52959-739563bbad4-fbe2-464f-8970-2a1d6aa7853212012-07-24
52959-739-14EA - Each52959-7394a9dd82a-9a9f-4049-8415-71dfa9ca1f8012012-07-24
52959-739-20EA - Each52959-739d684c010-abdd-4faa-9ba0-e04376694ecf12012-07-24

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
52959-739CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 4 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
52959-739-06529590739066 in 1 BOTTLE, PLASTICHistorical
52959-739-145295907391414 in 1 BOTTLE, PLASTICHistorical
52959-739-205295907392020 in 1 BOTTLE, PLASTICHistorical
52959-739-305295907393030 in 1 BOTTLE, PLASTICHistorical