ALENDRONATE SODIUM

Product NDC
50090-4076
11-digit product format
500904076
Labeler code
50090
Product ID
50090-4076_aff05ead-3677-44df-ad8f-4120542086ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076768
Marketing category
ANDA
Marketing start
2008-08-04
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4076-0ALENDRONATE SODIUM1 in 1 CARTONTABLET15
50090-4076-0ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4076-0EA - Each50090-4076f758d694-f7bf-4f85-9829-b1e2c7d934b212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4076ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210418_00d7c0c2-8f16-4c99-86d4-d7a53191f2c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronic acid 35 MG Oral TabletSCD00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY00d7c0c2-8f16-4c99-86d4-d7a53191f2c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4076-0500904076001 BLISTER PACK in 1 CARTON (50090-4076-0) > 4 TABLET in 1 BLISTER PACK1 blister pack2019-01-220000-00-00NoNoCurrent