FDA.reportPublic FDA data

Ibandronate Sodium

Product NDC
65862-237
11-digit product format
658620237
Labeler code
65862
Product ID
65862-237_ac6119dd-ca9a-4a6e-9a3b-4ddb60924abe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ibandronate Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204502
Marketing category
ANDA
Marketing start
2016-03-11
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
65862-237-03Ibandronate Sodium3 in 1 BLISTER PACKTABLET, FILM COATED312
65862-237-03Ibandronate Sodium1 in 1 CARTONTABLET, FILM COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-237-03EA - Each65862-2377c831447-4498-428d-ae68-33eeadafdcae12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-237IBANDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 2 package rows20240511_86c0b4ae-5e38-4efe-88af-50ac560e294f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904932ibandronate sodium 150 MG Oral TabletPSN86c0b4ae-5e38-4efe-88af-50ac560e294f12
904932ibandronic acid 150 MG Oral TabletSCD86c0b4ae-5e38-4efe-88af-50ac560e294f12
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSY86c0b4ae-5e38-4efe-88af-50ac560e294f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-237-03658620237031 BLISTER PACK in 1 CARTON (65862-237-03) / 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-03-110000-00-00NoNoCurrent
65862-237-26658620237262500 TABLET, FILM COATED in 1 BAG (65862-237-26)11-MAR-16Current