IBANDRONATE SODIUM

Product NDC
47781-103
11-digit product format
477810103
Labeler code
47781
Product ID
47781-103_86be42bb-38fd-8b9d-e5ee-43d0703d9fd0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen Inc.
Application
ANDA078998
Marketing category
ANDA
Marketing start
2014-05-01
Marketing end
0000-00-00
Substance
IBANDRONATE SODIUM
Active strength
150 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-103-07EA - Each47781-10363617f9a-2422-485a-9fc3-83464af2241112014-06-03
47781-103-21EA - Each47781-103c2c0ff18-6099-462a-b143-87c92a17bd4112021-11-09
47781-103-33EA - Each47781-103ec3513e1-1dbb-4314-ada7-65417c22047b12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBANDRONATE SODIUMACTIVE INGREDIENTJ12U072QL0IBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
IBANDRONIC ACIDACTIVE MOIETYUMD7G2653WIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RIBANDRONATE SODIUM TABLET [ALVOGEN INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-103IBANDRONATE SODIUM TABLET [ALVOGEN INC.]14Legacy NDC20241011_acbc54fc-4248-416f-849c-2cd3bed0a843.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-103-21477810103211 BLISTER PACK in 1 CARTON (47781-103-21) > 3 TABLET in 1 BLISTER PACK1 blister pack2019-12-180000-00-00NoNoCurrent
47781-103-33477810103333 BLISTER PACK in 1 BOX (47781-103-33) > 1 TABLET in 1 BLISTER PACK (47781-103-07) 3 blister pack2014-05-010000-00-00NoNoCurrent