FDA.reportPublic FDA data

Risedronate Sodium

Product NDC
60505-3165
11-digit product format
605053165
Labeler code
60505
Product ID
60505-3165_03750616-5c88-729a-215e-3d796f8ba6a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Risedronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA090877
Marketing category
ANDA
Marketing start
2015-11-30
Substance
RISEDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RISEDRONATE SODIUM35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiOFG5EXG60L
Rxcui905024, 905028, 905083

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
dc99ed49-98e9-42a6-aef0-a6dc585a6a09Product name420191002
a51ae56f-109a-47a0-9ce1-2b825be8c01bProduct name520190614
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-3165-0Risedronate Sodium4 in 1 BLISTER PACKTABLET, FILM COATED415
60505-3165-0Risedronate Sodium1 in 1 CARTONTABLET, FILM COATED115
60505-3165-2Risedronate Sodium3 in 1 CARTONTABLET, FILM COATED315
60505-3165-2Risedronate Sodium4 in 1 BLISTER PACKTABLET, FILM COATED415

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-3165-0EA - Each60505-316556dd97e4-c100-4c8c-8925-d0c27922fdd912016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RISEDRONATE SODIUM ANHYDROUSACTIVE INGREDIENTOFG5EXG60LRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
RISEDRONIC ACIDACTIVE MOIETYKM2Z91756ZRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
CrospovidoneINACTIVE INGREDIENT68401960MKRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-3165RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.]14Current NDC, Legacy NDC, 4 package rows20250411_b90f2e5b-10b8-29a7-0360-31bd0dae0ec2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905028risedronate sodium 150 MG Oral TabletPSNb90f2e5b-10b8-29a7-0360-31bd0dae0ec215
905024risedronate sodium 35 MG Oral TabletPSNb90f2e5b-10b8-29a7-0360-31bd0dae0ec215
905083risedronate sodium 75 MG Oral TabletPSNb90f2e5b-10b8-29a7-0360-31bd0dae0ec215
905028risedronate sodium 150 MG Oral TabletSCDb90f2e5b-10b8-29a7-0360-31bd0dae0ec215
905024risedronate sodium 35 MG Oral TabletSCDb90f2e5b-10b8-29a7-0360-31bd0dae0ec215
905083risedronate sodium 75 MG Oral TabletSCDb90f2e5b-10b8-29a7-0360-31bd0dae0ec215
905024risedronate sodium 35 MG Oral TabletPSN81702f21-3117-49ce-8e9b-2aa2648ba7c31
905024risedronate sodium 35 MG Oral TabletSCD81702f21-3117-49ce-8e9b-2aa2648ba7c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-3165-0605053165001 BLISTER PACK in 1 CARTON (60505-3165-0) / 4 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2015-11-300000-00-00NoNoCurrent
60505-3165-2605053165023 BLISTER PACK in 1 CARTON (60505-3165-2) / 4 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2015-11-300000-00-00NoNoCurrent