FDA.reportPublic FDA data

Cipro

Product NDC
50419-773
11-digit product format
504190773
Labeler code
50419
Product ID
50419-773_1b112839-6cf0-466a-9188-86fc5b1549f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
KIT
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA020780
Marketing category
NDA
Marketing start
1997-09-26
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cipro
Listing expiration
2027-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511, 205769, 205770, 213224, 213226, 309308, 309309, 309310

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
50419-773-01Cipro1 in 1 KITKIT132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-773-01ML - Milliliter50419-7733f21e26a-0b98-4c59-a2f3-5ec2adf245a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
POVIDONESINACTIVE INGREDIENTFZ989GH94ECIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
SUCROSEINACTIVE INGREDIENTC151H8M554CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15
WATERINACTIVE INGREDIENT059QF0KO0RCIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-773CIPRO (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED CIPRO (CIPROFLOXACIN) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]30Current NDC, Legacy NDC, 1 package rows20241218_888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213224Cipro 250 MG in 5 mL Oral SuspensionPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205769Cipro 250 MG Oral TabletPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213226Cipro 500 MG in 5 mL Oral SuspensionPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205770Cipro 500 MG Oral TabletPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309308ciprofloxacin 250 MG in 5 mL Oral SuspensionPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
197511ciprofloxacin 250 MG Oral TabletPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309310ciprofloxacin 500 MG in 5 mL Oral SuspensionPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309309ciprofloxacin 500 MG Oral TabletPSN888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213226ciprofloxacin 100 MG/ML Oral Suspension [Cipro]SBD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205769ciprofloxacin 250 MG Oral Tablet [Cipro]SBD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213224ciprofloxacin 50 MG/ML Oral Suspension [Cipro]SBD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205770ciprofloxacin 500 MG Oral Tablet [Cipro]SBD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309310ciprofloxacin 100 MG/ML Oral SuspensionSCD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
197511ciprofloxacin 250 MG Oral TabletSCD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309308ciprofloxacin 50 MG/ML Oral SuspensionSCD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309309ciprofloxacin 500 MG Oral TabletSCD888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205769Cipro (as ciprofloxacin hydrochloride) 250 MG Oral TabletSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205770Cipro (as ciprofloxacin hydrochloride) 500 MG Oral TabletSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213226Cipro 100 MG/ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205769Cipro 250 MG Oral TabletSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213224Cipro 250 MG per 5 ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213224Cipro 50 MG/ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
205770Cipro 500 MG Oral TabletSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
213226Cipro 500 MG per 5 ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309310ciprofloxacin (as ciprofloxacin hydrochloride) 100 MG/ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309308ciprofloxacin 250 MG per 5 ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032
309310ciprofloxacin 500 MG per 5 ML Oral SuspensionSY888dc7f9-ad9c-4c00-8d50-8ddfd9bd27c032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-773-01504190773011 KIT in 1 KIT (50419-773-01) * 100 mL in 1 BOTTLE, GLASS * 100 mL in 1 BOTTLE, GLASS1 kit1997-09-260000-00-00NoNoCurrent