FDA.reportPublic FDA data

ALENDRONATE SODIUM

Product NDC
70518-1192
11-digit product format
705181192
Labeler code
70518
Product ID
70518-1192_4d4cc131-e69c-4e1a-e063-6394a90a0454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076768
Marketing category
ANDA
Marketing start
2018-05-16
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

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
70518-1192-0ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET47
70518-1192-1ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET47
70518-1192-1ALENDRONATE SODIUM3 in 1 CARTONTABLET37

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1192ALENDRONATE SODIUM TABLET [REMEDYREPACK INC.]3Current NDC, 3 package rows20250508_c7e470d6-508e-466e-a78d-060bbbc9745c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNc7e470d6-508e-466e-a78d-060bbbc9745c7
904396alendronic acid 35 MG Oral TabletSCDc7e470d6-508e-466e-a78d-060bbbc9745c7
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYc7e470d6-508e-466e-a78d-060bbbc9745c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-1192-0705181192004 in 1 BLISTER PACKHistorical
70518-1192-1705181192013 BLISTER PACK in 1 CARTON (70518-1192-1) / 4 TABLET in 1 BLISTER PACK3 blister pack2024-01-12NoNoCurrent