alendronate sodium

Product NDC
55695-012
11-digit product format
556950012
Labeler code
55695
Product ID
55695-012_2e09c51d-a794-3ca7-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
ANDA076984
Marketing category
ANDA
Marketing start
2008-08-04
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
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
55695-012-00alendronate sodium1 in 1 BOX, UNIT-DOSETABLET14
55695-012-00alendronate sodium4 in 1 BLISTER PACKTABLET44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-012ALENDRONATE SODIUM TABLET [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]4Legacy NDC, 2 package rows20160316_2b58f07e-630a-0871-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN2b58f07e-630a-0871-e054-00144ff8d46c4
904431alendronic acid 70 MG Oral TabletSCD2b58f07e-630a-0871-e054-00144ff8d46c4
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY2b58f07e-630a-0871-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-012-00556950012001 in 1 BOX, UNIT-DOSEHistorical