NDC 0115-1679-30 - 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
0115-1679
Requested NDC
0115-1679-30
Package NDCs from labels
0115-1679-30, 0115-1679-34, 0115-1679-26
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
0115-1679-262020-12-29These 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
0115-1679-342020-12-29These 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
0115-1679-262020-09-27These 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
0115-1679-342020-09-27These 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
0115-1679-262020-09-25These 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
0115-1679-342020-09-25These 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
0115-1679-262020-07-22These 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
0115-1679-342020-07-22These 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
0115-1679-26Alendronate Sodium12 in 1 CARTONTABLET1240
0115-1679-30Alendronate Sodium1 in 1 BLISTER PACKTABLET140
0115-1679-34Alendronate Sodium4 in 1 CARTONTABLET440

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0115-1679ALENDRONATE 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
0115-1679-26EA - Each0115-16792405624c-7aec-4142-ae34-2152d94d37e512017-06-15
0115-1679-30EA - Each0115-16797a8a05f4-d6e0-4fb5-b8c5-3b503a933e3e12017-06-15
0115-1679-34EA - Each0115-16791ecbd50d-f5d0-4ec6-b9cf-d315c54b1b3c12017-03-06

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 2 of 2 · 24 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
rxcui: 904396
unii: 2UY4M2U3RA
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
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMAmneal Pharmaceuticals of New York LLCc23fb7fe-c6b9-4f77-bde7-992222b589d32021-02-02Warnings, Adverse reactionsExact identifier
application number: ANDA075710
ndc (package): 0115-1680-08
ndc (package): 0115-1678-08
ndc (package): 0115-1678-01
ndc (package): 0115-1679-26
ndc (package): 0115-1681-34
ndc (package): 0115-1676-08
ndc (package): 0115-1681-30
ndc (package): 0115-1679-30
ndc (package): 0115-1679-34
ndc (package): 0115-1681-26
ndc (package): 0115-1676-01
ndc (product): 0115-1680
ndc (product): 0115-1676
ndc (product): 0115-1681
ndc (product): 0115-1679
ndc (product): 0115-1678
ndc11 (package): 00115167930
rxcui: 904405
rxcui: 904425
rxcui: 904396
rxcui: 904431
rxcui: 904419
spl id: 0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1
spl set id: c23fb7fe-c6b9-4f77-bde7-992222b589d3
unii: 2UY4M2U3RA

Reported adverse events (FAERS/openFDA)#

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