Home NDC 78206-135 FOSAMAX
Product NDC 78206-135
11-digit product format 782060135
Labeler code 78206
Product ID 78206-135_1013aa0b-071e-46c4-8bed-207bb10ac2fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name alendronate sodium
Dosage form TABLET
Route ORAL
Labeler Organon LLC
Application NDA020560
Marketing category NDA
Marketing start 2021-06-01
Substance ALENDRONATE SODIUM
Active strength 70 mg/1
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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FOSAMAX ALENDRONATE SODIUM EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 N020560-002 FOSAMAX ALENDRONATE SODIUM EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1995-09-29 N020560-003 FOSAMAX ALENDRONATE SODIUM EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-04-25 N020560-004 FOSAMAX ALENDRONATE SODIUM EQ 35MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2000-10-20 N020560-005 FOSAMAX ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB RLD, RS 2000-10-20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 2 of 2 · 44 observed states.
Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2022-10-28 04:53 UTC 2022-10 N020560-005 AB 1 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020560-005 AB 1 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020560-005 AB 1 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N020560-005 AB 1 a50c72e98297…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base FOSAMAX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALENDRONATE SODIUM 70 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2UY4M2U3RA Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904431 Internal RxNorm lookup 904433 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78206-135-01 FOSAMAX 4 in 1 BLISTER PACK TABLET 4 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-135 FOSAMAX (ALENDRONATE SODIUM) TABLET [ORGANON LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240418_14e931fd-2c5f-4d90-b7db-5980706f4a56.zip
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 78206-135-01 78206013501 4 TABLET in 1 BLISTER PACK (78206-135-01) 4 tablet 2021-06-01 0000-00-00 No No Current