Alendronate Sodium

Product NDC
71205-048
11-digit product format
712050048
Labeler code
71205
Product ID
71205-048_6db7f218-1343-4b68-b72d-6605f1838e97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090124
Marketing category
ANDA
Marketing start
2008-08-04
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alendronate Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM70 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui904431

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
71205-048-04Alendronate Sodium4 in 1 BLISTER PACKTABLET45
71205-048-04Alendronate Sodium1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-048-04EA - Each71205-0486adc71e1-0155-405c-aac9-aaeaea91e35612018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-048ALENDRONATE SODIUM TABLET [PROFICIENT RX LP]5Current NDC, Legacy NDC, 2 package rows20230325_6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c5
904431alendronic acid 70 MG Oral TabletSCD6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c5
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-048-04712050048041 BLISTER PACK in 1 CARTON (71205-048-04) / 4 TABLET in 1 BLISTER PACK1 blister pack2018-06-010000-00-00NoNoCurrent