FDA.reportPublic FDA data

Alendronate

Product NDC
10135-718
11-digit product format
101350718
Labeler code
10135
Product ID
10135-718_3e74abef-2742-2bbe-e063-6394a90a12cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium tablet
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA090258
Marketing category
ANDA
Marketing start
2020-12-01
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alendronate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui904396, 904431

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-718-12Alendronate3 in 1 CARTONTABLET36
10135-718-12Alendronate4 in 1 BLISTER PACKTABLET46
10135-718-44Alendronate4 in 1 BLISTER PACKTABLET46
10135-718-44Alendronate1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-718-12EA - Each10135-71851f3eb64-31c8-49ae-974e-9fd1979bed5712021-06-02
10135-718-44EA - Each10135-71884ba797a-2515-4f1d-9761-f023829a281112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-718ALENDRONATE (ALENDRONATE SODIUM TABLET) TABLET [MARLEX PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240915_b63421af-ec03-1de7-e053-2a95a90abec6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNb63421af-ec03-1de7-e053-2a95a90abec66
904431alendronate sodium 70 MG Oral TabletPSNb63421af-ec03-1de7-e053-2a95a90abec66
904396alendronic acid 35 MG Oral TabletSCDb63421af-ec03-1de7-e053-2a95a90abec66
904431alendronic acid 70 MG Oral TabletSCDb63421af-ec03-1de7-e053-2a95a90abec66
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYb63421af-ec03-1de7-e053-2a95a90abec66
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYb63421af-ec03-1de7-e053-2a95a90abec66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-718-12101350718123 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACK3 blister pack2020-12-010000-00-00NoNoCurrent
10135-718-44101350718441 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACK1 blister pack2020-12-010000-00-00NoNoCurrent