ALENDRONATE SODIUM

Product NDC
68788-7130
11-digit product format
687887130
Labeler code
68788
Product ID
68788-7130_e88fb31d-cfc6-4e20-95fa-90fa26bf8644
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076768
Marketing category
ANDA
Marketing start
2018-03-30
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ALENDRONATE SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM70 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui904431

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
68788-7130-4ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7130-4EA - Each68788-7130d7149ad4-896a-47d4-a892-de1d3e26e6c612018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7130ALENDRONATE SODIUM TABLET [PREFERRED PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 1 package rows20250105_83e3ba94-d882-4b5c-87cb-af1eb0997efc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSN83e3ba94-d882-4b5c-87cb-af1eb0997efc9
904431alendronic acid 70 MG Oral TabletSCD83e3ba94-d882-4b5c-87cb-af1eb0997efc9
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY83e3ba94-d882-4b5c-87cb-af1eb0997efc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7130-4687887130044 TABLET in 1 BLISTER PACK (68788-7130-4) 4 tablet2018-03-300000-00-00NoNoCurrent