Alendronate Sodium

Product NDC
33261-993
11-digit product format
332610993
Labeler code
33261
Product ID
33261-993_78a8700b-3eb9-4c00-b274-3bddc6208a34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075710
Marketing category
ANDA
Marketing start
2008-02-06
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
33261-993-01Alendronate Sodium4 in 1 BOXTABLET41
33261-993-01Alendronate Sodium1 in 1 BLISTER PACKTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-993ALENDRONATE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20131203_f3840bb8-f1aa-4d20-bca1-c0b986e40f22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNf3840bb8-f1aa-4d20-bca1-c0b986e40f221
904396alendronic acid 35 MG Oral TabletSCDf3840bb8-f1aa-4d20-bca1-c0b986e40f221
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYf3840bb8-f1aa-4d20-bca1-c0b986e40f221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-993-01332610993014 in 1 BOXHistorical