Alendronate

Product NDC
10135-697
11-digit product format
101350697
Labeler code
10135
Product ID
10135-697_76e6ead3-9532-4206-ad5f-a4a8a1eba934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA090258
Marketing category
ANDA
Marketing start
2020-03-01
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
2021-12-31
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
10135-697-12Alendronate3 in 1 CARTONTABLET31
10135-697-12Alendronate4 in 1 BLISTER PACKTABLET41
10135-697-20Alendronate10 in 1 BLISTER PACKTABLET101
10135-697-20Alendronate2 in 1 CARTONTABLET21
10135-697-44Alendronate4 in 1 BLISTER PACKTABLET41
10135-697-44Alendronate1 in 1 CARTONTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-697-12EA - Each10135-69750c40f4a-fc15-4f28-898d-af777b8fc7c112020-05-08
10135-697-20EA - Each10135-697f89fd345-558d-4520-ba90-66b32d45e15c12020-05-08
10135-697-44EA - Each10135-69770f5bd3c-8372-449a-a82f-68331f902a0512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-697ALENDRONATE (ALENDRONATE SODIUM) TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 6 package rows20200410_c1e61b54-287f-47ed-9192-e3c98ecb2e06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNc1e61b54-287f-47ed-9192-e3c98ecb2e061
904431alendronate sodium 70 MG Oral TabletPSNc1e61b54-287f-47ed-9192-e3c98ecb2e061
904396alendronic acid 35 MG Oral TabletSCDc1e61b54-287f-47ed-9192-e3c98ecb2e061
904431alendronic acid 70 MG Oral TabletSCDc1e61b54-287f-47ed-9192-e3c98ecb2e061
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYc1e61b54-287f-47ed-9192-e3c98ecb2e061
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYc1e61b54-287f-47ed-9192-e3c98ecb2e061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-697-12101350697123 BLISTER PACK in 1 CARTON (10135-697-12) > 4 TABLET in 1 BLISTER PACK3 blister pack2020-03-010000-00-00NoNoCurrent
10135-697-20101350697202 BLISTER PACK in 1 CARTON (10135-697-20) > 10 TABLET in 1 BLISTER PACK2 blister pack2020-03-010000-00-00NoNoCurrent
10135-697-44101350697441 BLISTER PACK in 1 CARTON (10135-697-44) > 4 TABLET in 1 BLISTER PACK1 blister pack2020-03-010000-00-00NoNoCurrent