FDA.reportPublic FDA data

IBANDRONATE SODIUM

Product NDC
60505-2795
11-digit product format
605052795
Labeler code
60505
Product ID
60505-2795_31cdb988-ed22-4f0d-d1c2-8e89aae8c703
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Apotex Corp
Application
ANDA078948
Marketing category
ANDA
Marketing start
2012-03-19
Substance
IBANDRONATE SODIUM
Active strength
150 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
IBANDRONATE SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IBANDRONATE SODIUM150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ12U072QL0
Rxcui904932

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578Product name320180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2Product name420160310

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-2795-0IBANDRONATE SODIUM1 in 1 BLISTER PACKTABLET, FILM COATED120
60505-2795-0IBANDRONATE SODIUM3 in 1 PACKAGETABLET, FILM COATED320

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-2795-0EA - Each60505-279550331f9d-4515-4164-8df1-df5bb19aac7112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBANDRONATE SODIUMACTIVE INGREDIENTJ12U072QL0IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
IBANDRONIC ACIDACTIVE MOIETYUMD7G2653WIBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BIBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8
WATERINACTIVE INGREDIENT059QF0KO0RIBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-2795IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]17Current NDC, Legacy NDC, 2 package rows20250413_dd674424-b151-d7eb-3acf-b1589347f2f7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904932ibandronate sodium 150 MG Oral TabletPSNdd674424-b151-d7eb-3acf-b1589347f2f720
904932ibandronic acid 150 MG Oral TabletSCDdd674424-b151-d7eb-3acf-b1589347f2f720
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYdd674424-b151-d7eb-3acf-b1589347f2f720

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-2795-0605052795003 BLISTER PACK in 1 PACKAGE (60505-2795-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2012-03-190000-00-00NoNoCurrent