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 1 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c7e470d6-508e-466e-a78d-060bbbc9745c2026-07-03Warnings, Adverse reactionsExact identifier
rxcui: 904396
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.54d6543d-4239-58b1-e054-00144ff88e882026-06-23Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c4358ba7-1bf8-4b0a-9407-5ac279d045552026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMRising Pharma Holdings, Inc.ffdd2496-d253-419b-85a6-8c615f7545f12026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA090124
ndc (product): 64980-342
rxcui: 904396
rxcui: 904431
rxcui: 904419
spl id: ae2e410c-e759-4879-9b18-aba62f096312
spl set id: ffdd2496-d253-419b-85a6-8c615f7545f1
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMNorthStar Rx LLC4323d3aa-cbb0-41e2-aba7-7a94a05169932026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA090124
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutionsd52cf007-5775-4dea-9f43-b1907b6ffe812026-05-22Warnings, Adverse reactionsExact identifier
application number: ANDA090124
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMAurobindo Pharma Limited815a87c4-e489-4eb9-9a2e-fb7a16642f012026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA090124
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
ALENDRONATE SODIUMALENDRONATE SODIUMCipla USA Inc.e2fac28d-ad91-4cdc-a003-9fdeac073f762026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
unii: 2UY4M2U3RA
FOSAMAXALENDRONATE SODIUMOrganon LLC14e931fd-2c5f-4d90-b7db-5980706f4a562026-03-12Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMPreferred Pharmaceuticals Inc.83e3ba94-d882-4b5c-87cb-af1eb0997efc2026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutionseeb65442-6b3c-485c-9c5d-9cf40df4451e2026-02-13Warnings, Adverse reactionsExact identifier
application number: ANDA090124
ndc (package): 50090-5677-1
ndc (package): 50090-5677-0
ndc (product): 50090-5677
ndc11 (package): 50090567701
rxcui: 904431
spl id: 2e465e5f-913b-46e8-b69d-cfca38d04db7
spl set id: eeb65442-6b3c-485c-9c5d-9cf40df4451e
unii: 2UY4M2U3RA
BinostoALENDRONATE SODIUMRadius Health, Inc.09765234-01bc-40f7-b9bb-c167056f39092026-02-06Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
FOSAMAX PLUS DALENDRONATE SODIUM AND CHOLECALCIFEROLOrganon LLC10307e7e-9a84-4aa1-8c5c-4b209cffe4d12026-02-03Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
Alendronate SodiumALENDRONATE SODIUMHikma Pharmaceuticals USA Inc.c910bb05-279b-4ffa-a867-46f4a0853ed52026-01-15Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.a24fd39c-34a7-4de2-9439-781e612189ca2025-12-16Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMA-S Medication Solutionsfe1dd324-eb02-4a73-97f5-9b77a7df10a72025-12-05Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA

Reported adverse events (FAERS/openFDA)#

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