Ciprofloxacin

Product NDC
10544-603
11-digit product format
105440603
Labeler code
10544
Product ID
10544-603_a36b1389-0b15-4b35-a934-9702069d5314
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA076639
Marketing category
ANDA
Marketing start
2010-05-17
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-603-06Ciprofloxacin6 in 1 BOTTLETABLET61
10544-603-10Ciprofloxacin10 in 1 BOTTLETABLET101
10544-603-14Ciprofloxacin14 in 1 BOTTLETABLET141
10544-603-20Ciprofloxacin20 in 1 BOTTLETABLET201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-603-06EA - Each10544-60353f0df59-baa9-46a5-89ef-d41fec8e916012015-02-02
10544-603-10EA - Each10544-60358778b3c-3dc8-4244-8038-0af84215251e12015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-603CIPROFLOXACIN TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 4 package rows20100825_29980caf-43b4-4efe-a310-bf52150cc6a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197511ciprofloxacin 250 MG Oral TabletPSN29980caf-43b4-4efe-a310-bf52150cc6a61
197511ciprofloxacin 250 MG Oral TabletSCD29980caf-43b4-4efe-a310-bf52150cc6a61
197511ciprofloxacin 250 MG (as ciprofloxacin HCl 297 MG) Oral TabletSY29980caf-43b4-4efe-a310-bf52150cc6a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-603-06105440603066 in 1 BOTTLEHistorical
10544-603-101054406031010 in 1 BOTTLEHistorical
10544-603-141054406031414 in 1 BOTTLEHistorical
10544-603-201054406032020 in 1 BOTTLEHistorical