Home NDC 0006-0031-44 FOSAMAX
Product NDC 0006-0031
Requested package NDC 0006-0031-44
11-digit product format 000060031
Labeler code 0006
Product ID 0006-0031_37333f48-be6f-455d-878b-328bc51259c4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alendronate sodium
Dosage form TABLET
Route ORAL
Labeler Merck Sharp & Dohme Corp.
Application NDA020560
Marketing category NDA
Marketing start 1995-09-29
Marketing end 0000-00-00
Substance ALENDRONATE SODIUM
Active strength 70 mg/1
Pharmacologic classes Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2021-12-31
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 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020560-001 FOSAMAX ALENDRONATE SODIUM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 N020560-002 FOSAMAX ALENDRONATE SODIUM EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 N020560-003 FOSAMAX ALENDRONATE SODIUM EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 N020560-004 FOSAMAX ALENDRONATE SODIUM EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 N020560-005 FOSAMAX ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020560-005 AB
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 6 · 220 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 2026-10-15 13:18:30 2026-09 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 c2088c7a36db…2026-10-15 13:18:30 2026-09 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 c2088c7a36db…2026-09-14 22:38:34 2026-08 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020560-001 FOSAMAX EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020560-002 FOSAMAX EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020560-003 FOSAMAX EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020560-004 FOSAMAX EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020560-005 FOSAMAX EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20 b8a1b40f171c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ALENDRONATE SODIUM ACTIVE INGREDIENT 2UY4M2U3RA FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.] 32 ALENDRONIC ACID ACTIVE MOIETY X1J18R4W8P FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.] 32 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.] 32 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.] 32 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.] 32 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.] 32 ALENDRONATE SODIUM ACTIVE INGREDIENT 2UY4M2U3RA FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 ALENDRONIC ACID ACTIVE MOIETY X1J18R4W8P FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.] 1
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FOSAMAX ALENDRONATE SODIUM Organon LLC 14e931fd-2c5f-4d90-b7db-5980706f4a56 2026-03-12 Warnings, Adverse reactions Exact identifier application applno (NDA): 020560 application number: NDA020560
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 0006-0031-44 00006003144 4 TABLET in 1 BLISTER PACK (0006-0031-44) 4 tablet 1995-09-29 0000-00-00 No No Current