FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
64980-341
11-digit product format
649800341
Labeler code
64980
Product ID
64980-341_ac73eca3-eeb7-4be7-9b03-471c4941e5e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
Rxcui904396, 904419, 904431

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
64980-341-12Alendronate Sodium3 in 1 CARTONTABLET36
64980-341-12Alendronate Sodium4 in 1 BLISTER PACKTABLET46
64980-341-14Alendronate Sodium4 in 1 BLISTER PACKTABLET46
64980-341-14Alendronate Sodium1 in 1 CARTONTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-341ALENDRONATE SODIUM TABLET [RISING PHARMA HOLDINGS, INC.]5Current NDC, Legacy NDC, 4 package rows20240510_ffdd2496-d253-419b-85a6-8c615f7545f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904419alendronate sodium 10 MG Oral TabletPSNffdd2496-d253-419b-85a6-8c615f7545f16
904396alendronate sodium 35 MG Oral TabletPSNffdd2496-d253-419b-85a6-8c615f7545f16
904431alendronate sodium 70 MG Oral TabletPSNffdd2496-d253-419b-85a6-8c615f7545f16
904419alendronic acid 10 MG Oral TabletSCDffdd2496-d253-419b-85a6-8c615f7545f16
904396alendronic acid 35 MG Oral TabletSCDffdd2496-d253-419b-85a6-8c615f7545f16
904431alendronic acid 70 MG Oral TabletSCDffdd2496-d253-419b-85a6-8c615f7545f16
904419alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral TabletSYffdd2496-d253-419b-85a6-8c615f7545f16
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYffdd2496-d253-419b-85a6-8c615f7545f16
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYffdd2496-d253-419b-85a6-8c615f7545f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-341-12649800341123 BLISTER PACK in 1 CARTON (64980-341-12) / 4 TABLET in 1 BLISTER PACK3 blister pack2008-08-040000-00-00NoNoCurrent
64980-341-14649800341141 BLISTER PACK in 1 CARTON (64980-341-14) / 4 TABLET in 1 BLISTER PACK1 blister pack2008-08-040000-00-00NoNoCurrent