FDA.reportPublic FDA data

ALENDRONATE SODIUM

Product NDC
69097-224
11-digit product format
690970224
Labeler code
69097
Product ID
69097-224_1d9a10b4-dc2b-4d58-902a-f202535f4b11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA076768
Marketing category
ANDA
Marketing start
2008-08-04
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
Rxcui904396, 904431

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-224-16ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET411
69097-224-76ALENDRONATE SODIUM3 in 1 CARTONTABLET311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-224ALENDRONATE SODIUM TABLET [CIPLA USA INC.]8Current NDC, Legacy NDC, 2 package rows20201006_e2fac28d-ad91-4cdc-a003-9fdeac073f76.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904431alendronate sodium 70 MG Oral TabletPSNc4358ba7-1bf8-4b0a-9407-5ac279d0455522
904431alendronic acid 70 MG Oral TabletSCDc4358ba7-1bf8-4b0a-9407-5ac279d0455522
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYc4358ba7-1bf8-4b0a-9407-5ac279d0455522
904431alendronate sodium 70 MG Oral TabletPSNfe1dd324-eb02-4a73-97f5-9b77a7df10a712
904431alendronic acid 70 MG Oral TabletSCDfe1dd324-eb02-4a73-97f5-9b77a7df10a712
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYfe1dd324-eb02-4a73-97f5-9b77a7df10a712
904396alendronate sodium 35 MG Oral TabletPSNe2fac28d-ad91-4cdc-a003-9fdeac073f7611
904431alendronate sodium 70 MG Oral TabletPSNe2fac28d-ad91-4cdc-a003-9fdeac073f7611
904396alendronic acid 35 MG Oral TabletSCDe2fac28d-ad91-4cdc-a003-9fdeac073f7611
904431alendronic acid 70 MG Oral TabletSCDe2fac28d-ad91-4cdc-a003-9fdeac073f7611
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYe2fac28d-ad91-4cdc-a003-9fdeac073f7611
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYe2fac28d-ad91-4cdc-a003-9fdeac073f7611
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
904431alendronate sodium 70 MG Oral TabletPSN54d6543d-4239-58b1-e054-00144ff88e885
904431alendronic acid 70 MG Oral TabletSCD54d6543d-4239-58b1-e054-00144ff88e885
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY54d6543d-4239-58b1-e054-00144ff88e885
904431alendronate sodium 70 MG Oral TabletPSNf4c2b26c-3f23-7b30-e053-2a95a90aa6e02
904431alendronic acid 70 MG Oral TabletSCDf4c2b26c-3f23-7b30-e053-2a95a90aa6e02
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYf4c2b26c-3f23-7b30-e053-2a95a90aa6e02
904431alendronate sodium 70 MG Oral TabletPSN2baf8516-4148-9007-e063-6394a90a80941
904431alendronate sodium 70 MG Oral TabletPSN7ab508e6-0ef0-3d17-e053-2991aa0ae1d71
904431alendronic acid 70 MG Oral TabletSCD2baf8516-4148-9007-e063-6394a90a80941
904431alendronic acid 70 MG Oral TabletSCD7ab508e6-0ef0-3d17-e053-2991aa0ae1d71
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY7ab508e6-0ef0-3d17-e053-2991aa0ae1d71
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY2baf8516-4148-9007-e063-6394a90a80941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-224-16690970224164 in 1 BLISTER PACKHistorical
69097-224-76690970224763 BLISTER PACK in 1 CARTON (69097-224-76) / 4 TABLET in 1 BLISTER PACK (69097-224-16) 3 blister pack2008-08-040000-00-00NoNoCurrent