FDA.reportPublic FDA data

IBANDRONATE SODIUM

Product NDC
33342-150
11-digit product format
333420150
Labeler code
33342
Product ID
33342-150_29367df4-fac5-4117-963c-3e40ed998461
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA206887
Marketing category
ANDA
Marketing start
2018-06-13
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
33342-150-01IBANDRONATE SODIUM1 in 1 BLISTER PACKTABLET, FILM COATED112
33342-150-01IBANDRONATE SODIUM1 in 1 CARTONTABLET, FILM COATED112
33342-150-52IBANDRONATE SODIUM3 in 1 BLISTER PACKTABLET, FILM COATED312
33342-150-52IBANDRONATE SODIUM1 in 1 CARTONTABLET, FILM COATED112
33342-150-53IBANDRONATE SODIUM3 in 1 BOXTABLET, FILM COATED312

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-150-01EA - Each33342-1505d7b7664-e003-4839-93d1-7434fd13263212019-02-13
33342-150-52EA - Each33342-1507736c70d-63ee-45ec-b80d-baf15b97438e12025-07-08
33342-150-53EA - Each33342-150b880f9f9-888e-4f46-a956-4697cbdeb47c12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-150IBANDRONATE SODIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 5 package rows20220706_a5741ef6-0599-4657-8cda-2902ded4f680.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904932ibandronate sodium 150 MG Oral TabletPSNa5741ef6-0599-4657-8cda-2902ded4f68012
904932ibandronic acid 150 MG Oral TabletSCDa5741ef6-0599-4657-8cda-2902ded4f68012
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSYa5741ef6-0599-4657-8cda-2902ded4f68012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-150-01333420150011 in 1 BLISTER PACKHistorical
33342-150-52333420150521 BLISTER PACK in 1 CARTON (33342-150-52) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-07-01NoNoHistorical
33342-150-53333420150533 CARTON in 1 BOX (33342-150-53) / 1 BLISTER PACK in 1 CARTON (33342-150-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK3 carton2018-06-132027-12-31NoNoCurrent