FDA.reportPublic FDA data

NDC 16262-601-44 - Alendronate Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
16262-601
Requested NDC
16262-601-44
Package NDCs from labels
16262-601-44
Manufacturer
Dispensing Solutions Inc.
Effective date
2010-01-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALENDRONATE SODIUM TABLETS, USPDispensing Solutions Inc.2010-01-28HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALENDRONATE SODIUMACTIVE INGREDIENT2UY4M2U3RAALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.]1
alendronic acidACTIVE MOIETYX1J18R4W8PALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALENDRONATE SODIUM TABLET [DISPENSING SOLUTIONS INC.]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutions873442b0-1932-4fa6-ba25-b4d3505f41282024-11-13Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMEXELAN PHARMACEUTICALS INC.91a0f73a-d8cd-4197-b431-40707a2150b92023-08-25Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMProficient Rx LP6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c2023-03-01Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMAmneal Pharmaceuticals of New York LLCc23fb7fe-c6b9-4f77-bde7-992222b589d32021-02-02Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
8de3b358-74d1-485b-bf3d-f70a6140bf8162af73fb-c9b7-4034-9794-dbb50420e62b2010-01-28Warnings, Adverse reactionsExact identifier
spl id: 8de3b358-74d1-485b-bf3d-f70a6140bf81
spl set id: 62af73fb-c9b7-4034-9794-dbb50420e62b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.