FDA.reportPublic FDA data

NDC 50090-5677-01 - 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
50090-5677
Requested NDC
50090-5677-01
Package NDCs from labels
50090-5677-0, 50090-5677-1, 50090-5677-01
Manufacturer
A-S Medication Solutions
Effective date
2026-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alendronate Sodium - A-S Medication SolutionsA-S Medication Solutions2026-02-13Human Prescription Drug Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5677-02023-02-07These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
50090-5677-12023-02-07These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
50090-5677-02023-01-30These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
50090-5677-12023-01-30These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5677-0Alendronate Sodium4 in 1 BLISTER PACKTABLET411
50090-5677-0Alendronate Sodium1 in 1 CARTONTABLET111
50090-5677-1Alendronate Sodium3 in 1 CARTONTABLET311
50090-5677-1Alendronate Sodium4 in 1 BLISTER PACKTABLET411

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5677ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 4 package rows20231117_eeb65442-6b3c-485c-9c5d-9cf40df4451e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5677-0EA - Each50090-567766e8429a-87c5-469d-9fbd-eea9aab7340712022-10-06
50090-5677-1EA - Each50090-5677d33797ea-b6a4-4310-9e6e-b12b41d1df5212022-10-06

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 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alendronate SodiumALENDRONATE SODIUMANI Pharmaceuticals, Inc.81589178-10c9-4806-91eb-54e638d35b8d2025-10-29Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
AlendronateALENDRONATE SODIUM TABLETMarlex Pharmaceuticals, Inc.b63421af-ec03-1de7-e053-2a95a90abec62025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
unii: 2UY4M2U3RA
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals, Inc.2baf8516-4148-9007-e063-6394a90a80942025-01-14Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutions873442b0-1932-4fa6-ba25-b4d3505f41282024-11-13Warnings, Adverse reactionsExact identifier
application number: ANDA090124
rxcui: 904396
unii: 2UY4M2U3RA
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ALENDRONATE SODIUMALENDRONATE SODIUMEXELAN PHARMACEUTICALS INC.91a0f73a-d8cd-4197-b431-40707a2150b92023-08-25Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMProficient Rx LP6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c2023-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA090124
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMAmneal Pharmaceuticals of New York LLCc23fb7fe-c6b9-4f77-bde7-992222b589d32021-02-02Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA

Reported adverse events (FAERS/openFDA)#

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