ALENDRONATE SODIUM

Product NDC
61919-689
11-digit product format
619190689
Labeler code
61919
Product ID
61919-689_7ab508e6-0ef1-3d17-e053-2991aa0ae1d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALENDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA076768
Marketing category
ANDA
Marketing start
2018-11-15
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-689-042025-01-30C16284748780-12cef2736-8c7d-d83d-e063-dadaa90ab31fALENDRONATE SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-689-04ALENDRONATE SODIUM4 in 1 BOTTLETABLET41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-689-04EA - Each61919-689a20089c9-11d1-43c6-abb7-88d3b1c68a9f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-689ALENDRONATE SODIUM TABLET [DIRECT RX]1Legacy NDC, 1 package rows20190215_7ab508e6-0ef0-3d17-e053-2991aa0ae1d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN7ab508e6-0ef0-3d17-e053-2991aa0ae1d71
904431alendronic acid 70 MG Oral TabletSCD7ab508e6-0ef0-3d17-e053-2991aa0ae1d71
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY7ab508e6-0ef0-3d17-e053-2991aa0ae1d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-689-04619190689044 TABLET in 1 BOTTLE (61919-689-04) 4 tablet2018-11-150000-00-00NoNoCurrent