FDA.reportPublic FDA data

ciprofloxacin

Product NDC
43063-410
11-digit product format
430630410
Labeler code
43063
Product ID
43063-410_36b0c0b6-8368-77aa-e063-6394a90a0cc7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA076639
Marketing category
ANDA
Marketing start
2004-09-10
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Cytochrome P450 1A2 Inhibitors [MoA], Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ciprofloxacin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CIPROFLOXACIN HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4BA73M5E37
Rxcui197511

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
43063-410-06ciprofloxacin6 in 1 BOTTLE, PLASTICTABLET621
43063-410-10ciprofloxacin10 in 1 BOTTLE, PLASTICTABLET1021
43063-410-12ciprofloxacin12 in 1 BOTTLE, PLASTICTABLET1221
43063-410-14ciprofloxacin14 in 1 BOTTLE, PLASTICTABLET1421
43063-410-20ciprofloxacin20 in 1 BOTTLE, PLASTICTABLET2021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-410-06EA - Each43063-4100e2f8e8f-4ae1-481b-b8d1-134cc41ed15712013-02-13
43063-410-10EA - Each43063-410a76d4a5e-e13b-427b-b266-e5cb2345cd2812017-04-05
43063-410-12EA - Each43063-410fd7a281e-a5ab-4f5c-b3f5-66bdf0856da412013-02-13
43063-410-14EA - Each43063-4109d5417a0-ddf3-42d1-8dd2-012677a32ff312013-02-13
43063-410-20EA - Each43063-410aa13e5b7-2fb0-4295-b6bc-8c7e13d21c1612018-06-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-410CIPROFLOXACIN TABLET [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 5 package rows20250303_178dc379-e2b8-4b47-9f0c-3fc7fb435c36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN178dc379-e2b8-4b47-9f0c-3fc7fb435c3621
197511ciprofloxacin 250 MG Oral TabletSCD178dc379-e2b8-4b47-9f0c-3fc7fb435c3621
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY178dc379-e2b8-4b47-9f0c-3fc7fb435c3621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-410-06430630410066 TABLET in 1 BOTTLE, PLASTIC (43063-410-06) 6 tablet2012-01-230000-00-00NoNoCurrent
43063-410-104306304101010 TABLET in 1 BOTTLE, PLASTIC (43063-410-10) 10 tablet2017-03-010000-00-00NoNoCurrent
43063-410-124306304101212 TABLET in 1 BOTTLE, PLASTIC (43063-410-12) 12 tablet2012-12-060000-00-00NoNoCurrent
43063-410-144306304101414 TABLET in 1 BOTTLE, PLASTIC (43063-410-14) 14 tablet2013-02-080000-00-00NoNoCurrent
43063-410-204306304102020 TABLET in 1 BOTTLE, PLASTIC (43063-410-20) 20 tablet2014-05-060000-00-00NoNoCurrent