Ibandronate sodium

Product NDC
50090-7654
11-digit product format
500907654
Labeler code
50090
Product ID
50090-7654_1b55f284-94ab-46b3-bb1b-0ef5746bb901
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibandronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078997
Marketing category
ANDA
Marketing start
2012-06-21
Substance
IBANDRONATE SODIUM
Active strength
150 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ibandronate sodium
Listing expiration
2026-12-31

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
50090-7654-0Ibandronate sodium3 in 1 BLISTER PACKTABLET31
50090-7654-0Ibandronate sodium1 in 1 CARTONTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7654-0EA - Each50090-7654e0e3974d-91ba-415e-94b0-ed9b56dcf44212025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904932ibandronate sodium 150 MG Oral TabletPSNe5b6c2a9-a55f-41f9-a592-e26ef03e2d731
904932ibandronic acid 150 MG Oral TabletSCDe5b6c2a9-a55f-41f9-a592-e26ef03e2d731
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYe5b6c2a9-a55f-41f9-a592-e26ef03e2d731

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7654-0500907654001 BLISTER PACK in 1 CARTON (50090-7654-0) / 3 TABLET in 1 BLISTER PACK1 blister pack2025-09-17NoNoCurrent