FDA.reportPublic FDA data

ALENDRONATE SODIUM

Product NDC
69097-223
11-digit product format
690970223
Labeler code
69097
Product ID
69097-223_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
35 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 SODIUM35 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA

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
69097-223-16ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET411
69097-223-76ALENDRONATE SODIUM3 in 1 CARTONTABLET311

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-223-16EA - Each69097-2231141337f-fe33-479d-a5f8-22baf4e2809d12015-08-04
69097-223-76EA - Each69097-223141eec8a-93c4-4715-b764-f2eeebb752c512015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALENDRONATE SODIUMACTIVE INGREDIENT2UY4M2U3RAALENDRONATE SODIUM TABLET [CIPLA USA INC.]1
ALENDRONIC ACIDACTIVE MOIETYX1J18R4W8PALENDRONATE SODIUM TABLET [CIPLA USA INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALENDRONATE SODIUM TABLET [CIPLA USA INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALENDRONATE SODIUM TABLET [CIPLA USA INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AALENDRONATE SODIUM TABLET [CIPLA USA INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALENDRONATE SODIUM TABLET [CIPLA USA INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALENDRONATE SODIUM TABLET [CIPLA USA INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-223ALENDRONATE 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
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
904396alendronate sodium 35 MG Oral TabletPSNc7e470d6-508e-466e-a78d-060bbbc9745c7
904396alendronic acid 35 MG Oral TabletSCDc7e470d6-508e-466e-a78d-060bbbc9745c7
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYc7e470d6-508e-466e-a78d-060bbbc9745c7
904396alendronate sodium 35 MG Oral TabletPSN00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronic acid 35 MG Oral TabletSCD00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronate sodium 35 MG Oral TabletPSN7fbca6be-aaaf-19d4-e053-2991aa0a72eb1
904396alendronic acid 35 MG Oral TabletSCD7fbca6be-aaaf-19d4-e053-2991aa0a72eb1
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY7fbca6be-aaaf-19d4-e053-2991aa0a72eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-223-16690970223161 BLISTER PACK in 1 CARTON (69097-223-16) / 4 TABLET in 1 BLISTER PACK1 blister pack2008-08-040Current
69097-223-76690970223763 BLISTER PACK in 1 CARTON (69097-223-76) / 4 TABLET in 1 BLISTER PACK (69097-223-16) 3 blister pack2008-08-040000-00-00NoNoCurrent