Home NDC 0006-0710-44 FOSAMAX PLUS D
Product NDC 0006-0710
Requested package NDC 0006-0710-44
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021762-001 FOSAMAX PLUS D ALENDRONATE SODIUM; CHOLECALCIFEROL EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 N021762-002 FOSAMAX PLUS D ALENDRONATE SODIUM; CHOLECALCIFEROL EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021762-001 FOSAMAX PLUS D EQ 70MG BASE;2,800 IU TABLET / ORAL RLD 2005-04-07 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021762-002 FOSAMAX PLUS D EQ 70MG BASE;5,600 IU TABLET / ORAL RLD, RS 2007-04-26 74a2ff9319b5…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021762-001 5994329*PED 2019-01-17 Pediatric extension 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N021762-001 5994329*PED 2019-01-17 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021762-001 5994329*PED 2019-01-17 Pediatric extension b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021762-001 5994329*PED 2019-01-17 Pediatric extension ea99ee380514…
DailyMed Product Concepts# DailyMed Socrata Ingredients# 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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0006-0710-44 00006071044 4 TABLET in 1 BLISTER PACK (0006-0710-44) 4 tablet 2005-04-07 0000-00-00 No No Current