FDA.reportPublic FDA data

NDC 76282-682-45 - 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
76282-682
Requested NDC
76282-682-45
Package NDCs from labels
76282-682-45, 76282-682-46
Manufacturer
EXELAN PHARMACEUTICALS INC. | APPCO PHARMA LLC
Effective date
2023-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALENDRONATE SODIUM - EXELAN PHARMACEUTICALS INC. | APPCO PHARMA LLCEXELAN PHARMACEUTICALS INC. | APPCO PHARMA LLC2023-08-25HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76282-682-462023-08-29C16284748780-1e4f33bdf-9b5d-d8a0-e053-dadaa90a6e4eThese 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
76282-682-462022-07-29C16284748780-1e4f33bdf-9b5d-d8a0-e053-dadaa90a6e4eThese 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
76282-682-45ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET42
76282-682-46ALENDRONATE SODIUM3 in 1 CARTONTABLET32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-682ALENDRONATE SODIUM TABLET [EXELAN PHARMACEUTICALS INC.]2Current NDC, Legacy NDC, 2 package rows20230830_91a0f73a-d8cd-4197-b431-40707a2150b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-682-45EA - Each76282-682fbf37ece-6ab5-4a9e-a2ae-d96f41b4404d12021-12-08

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 · 40 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALENDRONATE SODIUMALENDRONATE SODIUMA-S Medication Solutionsfe1dd324-eb02-4a73-97f5-9b77a7df10a72025-12-05Warnings, Adverse reactionsExact identifier
application number: ANDA076768
rxcui: 904431
unii: 2UY4M2U3RA
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Alendronate SodiumALENDRONATE SODIUMANI Pharmaceuticals, Inc.81589178-10c9-4806-91eb-54e638d35b8d2025-10-29Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
MannitolMANNITOLICU Medical Inc.ba7bf864-8a4d-4262-8fd1-00174fa2f9d12025-10-24Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
AlendronateALENDRONATE SODIUM TABLETMarlex Pharmaceuticals, Inc.b63421af-ec03-1de7-e053-2a95a90abec62025-09-10Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
unii: 2UY4M2U3RA
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
application number: ANDA076768
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutions873442b0-1932-4fa6-ba25-b4d3505f41282024-11-13Warnings, Adverse reactionsExact identifier
rxcui: 904396
unii: 2UY4M2U3RA
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
MANNITOLMANNITOLHF Acquisition Co LLC, DBA HealthFirst999ce711-2d5b-0d7d-e053-2995a90a26892024-01-27Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
ALENDRONATE SODIUMALENDRONATE SODIUMEXELAN PHARMACEUTICALS INC.91a0f73a-d8cd-4197-b431-40707a2150b92023-08-25Warnings, Adverse reactionsExact identifier
application number: ANDA076768
ndc (package): 76282-682-45
ndc (package): 76282-682-46
ndc (package): 76282-681-46
ndc (package): 76282-681-45
ndc (product): 76282-682
ndc (product): 76282-681
ndc11 (package): 76282068245
rxcui: 904396
rxcui: 904431
spl id: 2012c7a8-8aa7-4c18-a8c3-fe74d74ac873
spl set id: 91a0f73a-d8cd-4197-b431-40707a2150b9
unii: 2UY4M2U3RA
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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: 904396
rxcui: 904431
unii: 2UY4M2U3RA

Reported adverse events (FAERS/openFDA)#

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