FOSAMAX PLUS D

Product NDC
0006-0710
11-digit product format
000060710
Labeler code
0006
Product ID
0006-0710_31045bcd-e069-4541-8cfb-58442e7c3435
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALENDRONATE SODIUM and CHOLECALCIFEROL
Dosage form
TABLET
Route
ORAL
Labeler
Merck Sharp & Dohme Corp.
Application
NDA021762
Marketing category
NDA
Marketing start
2005-04-07
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM; CHOLECALCIFEROL
Active strength
70 mg/1; [iU]/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS],Vitamin D [CS],Vitamin D [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0006-0710DDiscontinued by firm2026-08-17
excluded packagepackage0006-07100006-0710-44DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0006-0710-44d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0006-0710-44f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0006-0710-442ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0006-0710-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0006-0710-44cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0006-0710-44cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0006-0710-44302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0006-0710-44ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0006-0710-440efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0006-0710-44ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0006-0710-44367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0006-0710-44557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021762-001FOSAMAX PLUS DALENDRONATE SODIUM; CHOLECALCIFEROLEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07
N021762-002FOSAMAX PLUS DALENDRONATE SODIUM; CHOLECALCIFEROLEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07caaa826d4ba7…
2026-08-18 06:07:402026-07N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07d06236e962d9…
2024-10-29 15:01 UTC2024-10N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021762-001FOSAMAX PLUS DEQ 70MG BASE;2,800 IUTABLET / ORALRLD2005-04-07bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021762-002FOSAMAX PLUS DEQ 70MG BASE;5,600 IUTABLET / ORALRLD, RS2007-04-26bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021762-0015994329*PED2019-01-17Pediatric extension74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021762-0015994329*PED2019-01-17Pediatric extension3f01610625f2…
2019-09-15 20:21 UTC2019-09N021762-0015994329*PED2019-01-17Pediatric extensionb00525d2431f…
2019-07-19 19:46 UTC2019-07N021762-0015994329*PED2019-01-17Pediatric extensionea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-0710-44EA - Each0006-071077450881-91c2-4352-8103-08dd4633839a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALENDRONATE SODIUMACTIVE INGREDIENT2UY4M2U3RAFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF41FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
ALENDRONIC ACIDACTIVE MOIETYX1J18R4W8PFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF41FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
GELATININACTIVE INGREDIENT2G86QN327LFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
SODIUM ALUMINIUM SILICATEINACTIVE INGREDIENT058TS43PSMFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
SUCROSEINACTIVE INGREDIENTC151H8M554FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]25
alendronate sodiumACTIVE INGREDIENT2UY4M2U3RAFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
cholecalciferolACTIVE INGREDIENT1C6V77QF41FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
alendronic acidACTIVE MOIETYX1J18R4W8PFOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [PHYSICIANS TOTAL CARE, INC.]2
cholecalciferolACTIVE MOIETY1C6V77QF41FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [PHYSICIANS TOTAL CARE, INC.]2

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSAMAX PLUS DALENDRONATE SODIUM AND CHOLECALCIFEROLOrganon LLC10307e7e-9a84-4aa1-8c5c-4b209cffe4d12026-02-03Warnings, Adverse reactionsExact identifier
application applno (NDA): 021762
application number: NDA021762

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904492alendronate sodium 70 MG / cholecalciferol 2800 UNT Oral TabletPSNd4a71df1-7488-46a2-8ded-dd0db56de6182
904495FOSAMAX PLUS D 70 MG / 2800 UNT Oral TabletPSNd4a71df1-7488-46a2-8ded-dd0db56de6182
904495alendronic acid 70 MG / cholecalciferol 2800 UNT Oral Tablet [Fosamax Plus D]SBDd4a71df1-7488-46a2-8ded-dd0db56de6182
904492alendronic acid 70 MG / cholecalciferol 2800 UNT Oral TabletSCDd4a71df1-7488-46a2-8ded-dd0db56de6182
904492alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 2800 UNT Oral TabletSYd4a71df1-7488-46a2-8ded-dd0db56de6182
904492alendronic acid 70 MG / vitamin D3 2800 UNT Oral TabletSYd4a71df1-7488-46a2-8ded-dd0db56de6182
904495Fosamax Plus D 70/2800 (alendronic acid / vitamin D3) Oral TabletSYd4a71df1-7488-46a2-8ded-dd0db56de6182
904495Fosamax Plus D 70/2800 Oral TabletSYd4a71df1-7488-46a2-8ded-dd0db56de6182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0006-0710-44000060710444 TABLET in 1 BLISTER PACK (0006-0710-44) 4 tablet2005-04-070000-00-00NoNoCurrent