FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
65862-327
11-digit product format
658620327
Labeler code
65862
Product ID
65862-327_c2dfac3c-41f9-42fa-bb6b-54b3fd9d1512
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090124
Marketing category
ANDA
Marketing start
2008-08-04
Substance
ALENDRONATE SODIUM
Active strength
10 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
Alendronate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-327-01Alendronate Sodium100 in 1 BOTTLETABLET10027
65862-327-10Alendronate Sodium10 in 1 BLISTER PACKTABLET1027
65862-327-10Alendronate Sodium10 in 1 CARTONTABLET1027
65862-327-30Alendronate Sodium30 in 1 BOTTLETABLET3027
65862-327-99Alendronate Sodium1000 in 1 BOTTLETABLET100027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-327ALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]25Current NDC, Legacy NDC, 5 package rows20240426_815a87c4-e489-4eb9-9a2e-fb7a16642f01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904419alendronate sodium 10 MG Oral TabletPSN815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904396alendronate sodium 35 MG Oral TabletPSN815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904431alendronate sodium 70 MG Oral TabletPSN815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904419alendronic acid 10 MG Oral TabletSCD815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904396alendronic acid 35 MG Oral TabletSCD815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904431alendronic acid 70 MG Oral TabletSCD815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904419alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral TabletSY815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY815a87c4-e489-4eb9-9a2e-fb7a16642f0127
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY815a87c4-e489-4eb9-9a2e-fb7a16642f0127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-327-0165862032701100 TABLET in 1 BOTTLE (65862-327-01) 100 tablet2008-08-040000-00-00NoNoCurrent
65862-327-106586203271010 BLISTER PACK in 1 CARTON (65862-327-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2008-08-040000-00-00NoNoCurrent
65862-327-196586203271910000 TABLET in 1 BAG (65862-327-19)10000 tablet04-AUG-08Current
65862-327-306586203273030 TABLET in 1 BOTTLE (65862-327-30) 30 tablet2008-08-040000-00-00NoNoCurrent
65862-327-99658620327991000 TABLET in 1 BOTTLE (65862-327-99) 1000 tablet2008-08-040000-00-00NoNoCurrent