FDA.reportPublic FDA data

NDC 0115-1681-30 - 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
0115-1681
Requested NDC
0115-1681-30
Package NDCs from labels
0115-1681-30, 0115-1681-34, 0115-1681-26
Manufacturer
Amneal Pharmaceuticals of New York LLC
Effective date
2021-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alendronate Sodium - Amneal Pharmaceuticals of New York LLCAmneal Pharmaceuticals of New York LLC2021-02-02HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0115-1681-262020-12-29These 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
0115-1681-342020-12-29These 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
0115-1681-262020-09-27These 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
0115-1681-342020-09-27These 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
0115-1681-262020-09-25These 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
0115-1681-342020-09-25These 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
0115-1681-262020-07-22These 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
0115-1681-342020-07-22These 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
0115-1681-26Alendronate Sodium12 in 1 CARTONTABLET1240
0115-1681-30Alendronate Sodium1 in 1 BLISTER PACKTABLET140
0115-1681-34Alendronate Sodium4 in 1 CARTONTABLET440

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1681ALENDRONATE SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]40Current NDC, Legacy NDC, 3 package rows20231231_c23fb7fe-c6b9-4f77-bde7-992222b589d3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0115-1681-26EA - Each0115-168151673fd2-df3c-494c-b3c8-938f05ce6dd412017-03-06
0115-1681-30EA - Each0115-168157202b10-c9fb-48af-9dca-85be165c9d9c12017-03-06
0115-1681-34EA - Each0115-16817ca5138a-87ad-44a8-a6a3-7a40aebfd88a12017-03-06

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 · 24 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
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMNorthStar Rx LLC4323d3aa-cbb0-41e2-aba7-7a94a05169932026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutionsd52cf007-5775-4dea-9f43-b1907b6ffe812026-05-22Warnings, Adverse reactionsExact identifier
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMAurobindo Pharma Limited815a87c4-e489-4eb9-9a2e-fb7a16642f012026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA
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
rxcui: 904431
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
Alendronate SodiumALENDRONATE SODIUMHikma Pharmaceuticals USA Inc.c910bb05-279b-4ffa-a867-46f4a0853ed52026-01-15Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
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
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

Reported adverse events (FAERS/openFDA)#

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