CIPROFLOXACIN

Product NDC
10544-607
11-digit product format
105440607
Labeler code
10544
Product ID
10544-607_c496b063-27b8-4675-aafc-6b65dd5aee3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075593
Marketing category
ANDA
Marketing start
2010-05-17
Marketing end
0000-00-00
Substance
CIPROFLOXACIN HYDROCHLORIDE
Active strength
500 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
10544-607-06CIPROFLOXACIN6 in 1 BOTTLETABLET, FILM COATED61
10544-607-10CIPROFLOXACIN10 in 1 BOTTLETABLET, FILM COATED101
10544-607-14CIPROFLOXACIN14 in 1 BOTTLETABLET, FILM COATED141
10544-607-20CIPROFLOXACIN20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-607-06EA - Each10544-60727b858a9-fe72-4762-8054-4f91776d7e5912015-02-02
10544-607-10EA - Each10544-607f3b9623d-e264-4ebc-bec9-5b92a6e31d7a12015-02-02
10544-607-14EA - Each10544-6074f01931c-0bce-47ae-9022-d4897b88852612015-02-02
10544-607-20EA - Each10544-607deda492e-d743-4334-b1d4-f85f165dc39912015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ciprofloxacin hydrochlorideACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
ciprofloxacinACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
HYPROMELLOSE 2910 (5 CPS)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-607CIPROFLOXACIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 4 package rows20100913_4ce6888c-e639-4a0c-8490-2a78bcaa41e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN4ce6888c-e639-4a0c-8490-2a78bcaa41e91
309309ciprofloxacin 500 MG Oral TabletSCD4ce6888c-e639-4a0c-8490-2a78bcaa41e91
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY4ce6888c-e639-4a0c-8490-2a78bcaa41e91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-607-06105440607066 in 1 BOTTLEHistorical
10544-607-101054406071010 in 1 BOTTLEHistorical
10544-607-141054406071414 in 1 BOTTLEHistorical
10544-607-201054406072020 in 1 BOTTLEHistorical