FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
65862-328
11-digit product format
658620328
Labeler code
65862
Product ID
65862-328_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
35 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 SODIUM35 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
65862-328-04Alendronate Sodium4 in 1 BLISTER PACKTABLET427
65862-328-04Alendronate Sodium1 in 1 CARTONTABLET127
65862-328-08Alendronate Sodium4 in 1 BLISTER PACKTABLET427
65862-328-08Alendronate Sodium3 in 1 CARTONTABLET327
65862-328-10Alendronate Sodium10 in 1 CARTONTABLET1027
65862-328-10Alendronate Sodium10 in 1 BLISTER PACKTABLET1027
65862-328-20Alendronate Sodium4 in 1 BLISTER PACKTABLET427
65862-328-20Alendronate Sodium5 in 1 CARTONTABLET527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-328-04EA - Each65862-3282debbf72-33e4-4eeb-9418-eb15b98cfa8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALENDRONATE SODIUMACTIVE INGREDIENT2UY4M2U3RAALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15
ALENDRONIC ACIDACTIVE MOIETYX1J18R4W8PALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-328ALENDRONATE SODIUM TABLET [AUROBINDO PHARMA LIMITED]25Current NDC, Legacy NDC, 8 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
65862-328-04658620328041 BLISTER PACK in 1 CARTON (65862-328-04) / 4 TABLET in 1 BLISTER PACK1 blister pack2008-08-040000-00-00NoNoCurrent
65862-328-08658620328083 BLISTER PACK in 1 CARTON (65862-328-08) / 4 TABLET in 1 BLISTER PACK3 blister pack2008-08-040000-00-00NoNoCurrent
65862-328-106586203281010 BLISTER PACK in 1 CARTON (65862-328-10) / 10 TABLET in 1 BLISTER PACK10 blister pack2008-08-040000-00-00NoNoCurrent
65862-328-20658620328205 BLISTER PACK in 1 CARTON (65862-328-20) / 4 TABLET in 1 BLISTER PACK5 blister pack2008-08-040000-00-00NoNoCurrent
65862-328-49658620328494000 TABLET in 1 BAG (65862-328-49)4000 tablet04-AUG-08Current