IBANDRONATE SODIUM

Product NDC
60429-643
11-digit product format
604290643
Labeler code
60429
Product ID
60429-643_4b35c1c6-29e6-40f7-e063-6294a90ada88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA078948
Marketing category
ANDA
Marketing start
2012-03-19
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
60429-643-73IBANDRONATE SODIUM3 in 1 PACKAGETABLET, FILM COATED312
60429-643-73IBANDRONATE SODIUM1 in 1 BLISTER PACKTABLET, FILM COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-643-73EA - Each60429-643ad6bca4b-b411-4ef3-8048-4f19118e5aa912016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-643IBANDRONATE SODIUM TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]10Current NDC, Legacy NDC, 2 package rows20241212_618e1aff-ccbb-4cee-93f1-fe04e33dacb7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904932ibandronate sodium 150 MG Oral TabletPSN618e1aff-ccbb-4cee-93f1-fe04e33dacb712
904932ibandronic acid 150 MG Oral TabletSCD618e1aff-ccbb-4cee-93f1-fe04e33dacb712
904932ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral TabletSY618e1aff-ccbb-4cee-93f1-fe04e33dacb712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-643-73604290643733 BLISTER PACK in 1 PACKAGE (60429-643-73) / 1 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2016-02-050000-00-00NoNoCurrent