FDA.reportPublic FDA data

NDC 70518-0033-00 - 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
70518-0033
Requested NDC
70518-0033-00
Package NDCs from labels
70518-0033-0, 70518-0033-1, 70518-0033-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ALENDRONATE SODIUM - REMEDYREPACK INC.REMEDYREPACK INC.2026-06-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0033-0ALENDRONATE SODIUM12 in 1 BLISTER PACKTABLET1222
70518-0033-1ALENDRONATE SODIUM12 in 1 BOTTLE, PLASTICTABLET1222

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0033ALENDRONATE SODIUM TABLET [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 2 package rows20250524_c4358ba7-1bf8-4b0a-9407-5ac279d04555.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0033-0EA - Each70518-00331663f18b-5d03-4237-b079-9543c52a85b112025-12-16

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 · 40 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
application number: ANDA076768
rxcui: 904396
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.54d6543d-4239-58b1-e054-00144ff88e882026-06-23Warnings, Adverse reactionsExact identifier
application number: ANDA076768
rxcui: 904431
unii: 2UY4M2U3RA
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c4358ba7-1bf8-4b0a-9407-5ac279d045552026-06-22Warnings, Adverse reactionsExact identifier
application number: ANDA076768
ndc (package): 70518-0033-0
ndc (package): 70518-0033-1
ndc (product): 70518-0033
ndc11 (package): 70518003300
rxcui: 904431
spl id: 54dc50d7-1915-d260-e063-6394a90aae7d
spl set id: c4358ba7-1bf8-4b0a-9407-5ac279d04555
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMRising Pharma Holdings, Inc.ffdd2496-d253-419b-85a6-8c615f7545f12026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMNorthStar Rx LLC4323d3aa-cbb0-41e2-aba7-7a94a05169932026-06-12Warnings, Adverse reactionsExact identifier
rxcui: 904396
rxcui: 904431
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
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
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
ALENDRONATE SODIUMALENDRONATE SODIUMCipla USA Inc.e2fac28d-ad91-4cdc-a003-9fdeac073f762026-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA076768
ndc (product): 69097-224
rxcui: 904396
rxcui: 904431
spl id: 596c3f30-9197-4456-97d0-16e5bb2deb8f
spl set id: e2fac28d-ad91-4cdc-a003-9fdeac073f76
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
application number: ANDA076768
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
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

Reported adverse events (FAERS/openFDA)#

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