FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
59651-867
11-digit product format
596510867
Labeler code
59651
Product ID
59651-867_99cc20d5-219c-4118-83ad-77df85348735
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077859
Marketing category
ANDA
Marketing start
2024-02-09
Marketing end
2028-02-29
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ciprofloxacin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 197512, 309309

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-867-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1004
59651-867-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED5004
59651-867-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED204
59651-867-30Ciprofloxacin30 in 1 BOTTLETABLET, FILM COATED304
59651-867-99Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-867-01EA - Each59651-867d3cc6a1f-d2cd-4944-af7f-a92f534407a312024-07-12
59651-867-05EA - Each59651-86731ecfd68-8deb-429f-8535-dd3d8125e6da12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-867CIPROFLOXACIN (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]3Current NDC, 5 package rows20250501_7041828f-d4ec-4813-bcac-cb335c6c312a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSNa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin 500 MG Oral TabletSCDa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSYa914512b-9a4a-4c53-ab7a-2e2b1ea8a0127
309309ciprofloxacin 500 MG Oral TabletPSN47d1e4c5-f669-4aca-9e8c-0d6bb833b8595
309309ciprofloxacin 500 MG Oral TabletSCD47d1e4c5-f669-4aca-9e8c-0d6bb833b8595
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY47d1e4c5-f669-4aca-9e8c-0d6bb833b8595
197511ciprofloxacin 250 MG Oral TabletPSN7041828f-d4ec-4813-bcac-cb335c6c312a4
309309ciprofloxacin 500 MG Oral TabletPSN7041828f-d4ec-4813-bcac-cb335c6c312a4
197512ciprofloxacin 750 MG Oral TabletPSN7041828f-d4ec-4813-bcac-cb335c6c312a4
197511ciprofloxacin 250 MG Oral TabletSCD7041828f-d4ec-4813-bcac-cb335c6c312a4
309309ciprofloxacin 500 MG Oral TabletSCD7041828f-d4ec-4813-bcac-cb335c6c312a4
197512ciprofloxacin 750 MG Oral TabletSCD7041828f-d4ec-4813-bcac-cb335c6c312a4
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY7041828f-d4ec-4813-bcac-cb335c6c312a4
197512ciprofloxacin (as ciprofloxacin hydrochloride) 750 MG Oral TabletSY7041828f-d4ec-4813-bcac-cb335c6c312a4
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY7041828f-d4ec-4813-bcac-cb335c6c312a4
309309ciprofloxacin 500 MG Oral TabletPSN0fac4466-fbe5-49d2-96e3-e3ac2739bd5b3
309309ciprofloxacin 500 MG Oral TabletSCD0fac4466-fbe5-49d2-96e3-e3ac2739bd5b3
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY0fac4466-fbe5-49d2-96e3-e3ac2739bd5b3
309309ciprofloxacin 500 MG Oral TabletPSN3c611c8c-deed-4904-93f7-f75a2147fbf72
309309ciprofloxacin 500 MG Oral TabletPSN36d6c27d-45dc-3081-e063-6394a90a87e92
309309ciprofloxacin 500 MG Oral TabletPSN60cbce40-4969-42a3-9645-2158261375ef2
309309ciprofloxacin 500 MG Oral TabletPSN2c39e226-68c0-b0e5-e063-6394a90adc072
309309ciprofloxacin 500 MG Oral TabletSCD2c39e226-68c0-b0e5-e063-6394a90adc072
309309ciprofloxacin 500 MG Oral TabletSCD60cbce40-4969-42a3-9645-2158261375ef2
309309ciprofloxacin 500 MG Oral TabletSCD3c611c8c-deed-4904-93f7-f75a2147fbf72
309309ciprofloxacin 500 MG Oral TabletSCD36d6c27d-45dc-3081-e063-6394a90a87e92
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY60cbce40-4969-42a3-9645-2158261375ef2
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3c611c8c-deed-4904-93f7-f75a2147fbf72
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY36d6c27d-45dc-3081-e063-6394a90a87e92
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY2c39e226-68c0-b0e5-e063-6394a90adc072
309309ciprofloxacin 500 MG Oral TabletPSN26a51ac8-82dc-7614-e063-6394a90a54121
309309ciprofloxacin 500 MG Oral TabletSCD26a51ac8-82dc-7614-e063-6394a90a54121
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY26a51ac8-82dc-7614-e063-6394a90a54121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-867-0159651086701100 TABLET, FILM COATED in 1 BOTTLE (59651-867-01) 2024-02-092028-02-29NoNoHistorical
59651-867-0559651086705500 TABLET, FILM COATED in 1 BOTTLE (59651-867-05) 2024-02-092028-02-29NoNoHistorical
59651-867-205965108672020 in 1 BOTTLEHistorical
59651-867-305965108673030 in 1 BOTTLEHistorical
59651-867-99596510867991000 in 1 BOTTLEHistorical