FDA.reportPublic FDA data

Ciprofloxacin

Product NDC
59651-873
11-digit product format
596510873
Labeler code
59651
Product ID
59651-873_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
750 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 HYDROCHLORIDE750 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
59651-873-01Ciprofloxacin100 in 1 BOTTLETABLET, FILM COATED1004
59651-873-05Ciprofloxacin500 in 1 BOTTLETABLET, FILM COATED5004
59651-873-20Ciprofloxacin20 in 1 BOTTLETABLET, FILM COATED204
59651-873-50Ciprofloxacin50 in 1 BOTTLETABLET, FILM COATED504
59651-873-98Ciprofloxacin1000 in 1 BOTTLETABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-873-50EA - Each59651-8735e84886c-4bcc-4345-8cfb-1b96757c1d2212024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-873CIPROFLOXACIN (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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59651-873-0159651087301100 in 1 BOTTLEHistorical
59651-873-0559651087305500 in 1 BOTTLEHistorical
59651-873-205965108732020 in 1 BOTTLEHistorical
59651-873-505965108735050 TABLET, FILM COATED in 1 BOTTLE (59651-873-50) 2024-02-092028-02-29NoNoHistorical
59651-873-98596510873981000 in 1 BOTTLEHistorical