Boniva

Product NDC
0004-0186
11-digit product format
000040186
Labeler code
0004
Product ID
0004-0186_ea7ba1c4-117f-4670-8575-0cde1c39a61a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ibandronate sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Genentech, Inc.
Application
NDA021455
Marketing category
NDA
Marketing start
2005-03-24
Marketing end
2023-07-31
Substance
IBANDRONATE SODIUM
Active strength
150 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0186-82EA - Each0004-01867d36a8ea-ec42-4d0d-92c9-9d3ac91a6fbe12012-07-24
0004-0186-83EA - Each0004-018605c92b0e-b5e9-47c2-853a-e9cc6d6cf6dd12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBANDRONATE SODIUMACTIVE INGREDIENTJ12U072QL0BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
IBANDRONIC ACIDACTIVE MOIETYUMD7G2653WBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904934Boniva 150 MG Oral TabletPSNd6d7711f-541b-47d1-b937-2c6a021eb6c31
904932ibandronate sodium 150 MG Oral TabletPSNd6d7711f-541b-47d1-b937-2c6a021eb6c31
904934ibandronic acid 150 MG Oral Tablet [Boniva]SBDd6d7711f-541b-47d1-b937-2c6a021eb6c31
904932ibandronic acid 150 MG Oral TabletSCDd6d7711f-541b-47d1-b937-2c6a021eb6c31
904934Boniva 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYd6d7711f-541b-47d1-b937-2c6a021eb6c31
904934Boniva 150 MG Oral TabletSYd6d7711f-541b-47d1-b937-2c6a021eb6c31
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYd6d7711f-541b-47d1-b937-2c6a021eb6c31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0004-0186-83000040186831 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2014-12-170000-00-00NoNoCurrent