FDA.reportPublic FDA data

IBANDRONATE SODIUM

Product NDC
62756-218
11-digit product format
627560218
Labeler code
62756
Product ID
62756-218_61378ee8-cc2f-4f55-954b-4eb55e975f5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IBANDRONATE SODIUM
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090853
Marketing category
ANDA
Marketing start
2014-02-15
Substance
IBANDRONATE SODIUM
Active strength
3 mg/3mL
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 SODIUM3 mg/3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJ12U072QL0
Rxcui904955

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578Product name320180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2Product name420160310
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62756-218-402020-01-31C16284748780-19d75b9d0-64a2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-218-40IBANDRONATE SODIUM1 in 1 CARTONINJECTION, SOLUTION16
62756-218-40IBANDRONATE SODIUM3 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION36

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-218-40ML - Milliliter62756-218565fb9b7-bd67-4701-add4-fc4a163300bd12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBANDRONATE SODIUMACTIVE INGREDIENTJ12U072QL0IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
IBANDRONIC ACIDACTIVE MOIETYUMD7G2653WIBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PIBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BIBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XIBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4
WATERINACTIVE INGREDIENT059QF0KO0RIBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-218IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 2 package rows20181026_be514be6-727a-4d6c-993b-52144f8e6de8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904955ibandronate sodium 3 MG in 3 ML InjectionPSNbe514be6-727a-4d6c-993b-52144f8e6de86
9049553 ML ibandronic acid 1 MG/ML InjectionSCDbe514be6-727a-4d6c-993b-52144f8e6de86
904955ibandronic acid 1 MG/ML (as ibandronate sodium 1.13 MG/ML) InjectionSYbe514be6-727a-4d6c-993b-52144f8e6de86
904955ibandronic acid 3 MG per 3 ML (as ibandronate sodium 1.13 MG/ML) InjectionSYbe514be6-727a-4d6c-993b-52144f8e6de86

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62756-218-40627560218401 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) / 3 mL in 1 VIAL, SINGLE-DOSE2014-02-15NoNoCurrent