alendronate sodium

Product NDC
50090-1091
11-digit product format
500901091
Labeler code
50090
Product ID
50090-1091_2ebcc844-dc8c-43cc-83e2-09254cfb47e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076984
Marketing category
ANDA
Marketing start
2009-10-23
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
2019-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1091-0alendronate sodium4 in 1 BLISTER PACKTABLET48
50090-1091-0alendronate sodium1 in 1 BOX, UNIT-DOSETABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1091ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20180828_532987e4-cfe5-4902-9ea9-6555b101548c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN532987e4-cfe5-4902-9ea9-6555b101548c8
904431alendronate sodium 70 MG Oral TabletPSN532987e4-cfe5-4902-9ea9-6555b101548c8
904396alendronic acid 35 MG Oral TabletSCD532987e4-cfe5-4902-9ea9-6555b101548c8
904431alendronic acid 70 MG Oral TabletSCD532987e4-cfe5-4902-9ea9-6555b101548c8
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY532987e4-cfe5-4902-9ea9-6555b101548c8
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY532987e4-cfe5-4902-9ea9-6555b101548c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1091-0500901091004 in 1 BLISTER PACKHistorical