Ciprofloxacin Hydrochloride

Product NDC
49349-612
11-digit product format
493490612
Labeler code
49349
Product ID
49349-612_4bfdbcb4-ab48-4a25-963d-b7955b2eede9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ciprofloxacin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075593
Marketing category
ANDA
Marketing start
2011-03-15
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49349-612-022019-10-29C16284748780-1960f7f55-cb42-8e05-e053-dbdaa90a074a3e463126-78a9-4ec5-904c-0424a64d8ae8
49349-612-032019-10-29C16284748780-1960f7f55-da12-8e05-e053-dbdaa90a074a9dac97a5-c992-4601-af93-138bfe2302a8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49349-612-02Ciprofloxacin Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED301
49349-612-03Ciprofloxacin Hydrochloride20 in 1 BLISTER PACKTABLET, FILM COATED201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
CIPROFLOXACIN HYDROCHLORIDEACTIVE INGREDIENT4BA73M5E37CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
CIPROFLOXACINACTIVE MOIETY5E8K9I0O4UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49349-612CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1Legacy NDC, 1 package rows20110525_3e463126-78a9-4ec5-904c-0424a64d8ae8.zip
49349-612CIPROFLOXACIN HYDROCHLORIDE (CIPROFLOXACIN HYDROCHLORIDE) TABLET, FILM COATED [REMEDYREPACK INC. ]1Legacy NDC, 1 package rows20110524_9dac97a5-c992-4601-af93-138bfe2302a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309309ciprofloxacin 500 MG Oral TabletPSN3e463126-78a9-4ec5-904c-0424a64d8ae81
309309ciprofloxacin 500 MG Oral TabletPSN9dac97a5-c992-4601-af93-138bfe2302a81
309309ciprofloxacin 500 MG Oral TabletSCD3e463126-78a9-4ec5-904c-0424a64d8ae81
309309ciprofloxacin 500 MG Oral TabletSCD9dac97a5-c992-4601-af93-138bfe2302a81
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY3e463126-78a9-4ec5-904c-0424a64d8ae81
309309ciprofloxacin (as ciprofloxacin HCl) 500 MG Oral TabletSY9dac97a5-c992-4601-af93-138bfe2302a81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49349-612-024934906120230 in 1 BLISTER PACKHistorical
49349-612-034934906120320 in 1 BLISTER PACKHistorical