FDA.reportPublic FDA data

NDC 16714-631-10 - 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
16714-631
Requested NDC
16714-631-10
Package NDCs from labels
16714-631-01, 16714-631-02, 16714-631-10, 16714-631-11
Manufacturer
NorthStar Rx LLC | Aurobindo Pharma Limited
Effective date
2026-06-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Alendronate Sodium - NorthStar Rx LLC | Aurobindo Pharma LimitedNorthStar Rx LLC | Aurobindo Pharma Limited2026-06-12Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16714-631-01Alendronate Sodium30 in 1 BOTTLETABLET3016
16714-631-02Alendronate Sodium100 in 1 BOTTLETABLET10016
16714-631-10Alendronate Sodium10 in 1 BLISTER PACKTABLET1016
16714-631-11Alendronate Sodium10 in 1 CARTONTABLET1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-631ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]15Current NDC, Legacy NDC, 4 package rows20240426_4323d3aa-cbb0-41e2-aba7-7a94a0516993.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-631-01EA - Each16714-6319bf6b626-8ecf-4a7d-9313-9efea63c476412012-07-24
16714-631-02EA - Each16714-63197205e6b-fbc8-4fe2-9803-8caed011176412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALENDRONATE SODIUMACTIVE INGREDIENT2UY4M2U3RAALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
ALENDRONIC ACIDACTIVE MOIETYX1J18R4W8PALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7

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
rxcui: 904396
rxcui: 904431
rxcui: 904419
unii: 2UY4M2U3RA
Alendronate SodiumALENDRONATE SODIUMNorthStar Rx LLC4323d3aa-cbb0-41e2-aba7-7a94a05169932026-06-12Warnings, Adverse reactionsExact identifier
application number: ANDA090124
ndc (package): 16714-632-02
ndc (package): 16714-631-02
ndc (package): 16714-631-01
ndc (package): 16714-633-02
ndc (package): 16714-633-11
ndc (package): 16714-631-11
ndc (package): 16714-633-01
ndc (package): 16714-632-01
ndc (package): 16714-632-10
ndc (package): 16714-633-10
ndc (package): 16714-632-11
ndc (package): 16714-631-10
ndc (product): 16714-632
ndc (product): 16714-631
ndc (product): 16714-633
ndc11 (package): 16714063110
rxcui: 904396
rxcui: 904431
rxcui: 904419
spl id: aed28579-c63c-48b1-8b67-e24137d0709a
spl set id: 4323d3aa-cbb0-41e2-aba7-7a94a0516993
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
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
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.