Home NDC 10135-696-12 Alendronate
Product NDC 10135-696
Requested package NDC 10135-696-12
11-digit product format 101350696
Labeler code 10135
Product ID 10135-696_76e6ead3-9532-4206-ad5f-a4a8a1eba934
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alendronate Sodium
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals Inc
Application ANDA090258
Marketing category ANDA
Marketing start 2020-03-01
Marketing end 0000-00-00
Substance ALENDRONATE SODIUM
Active strength 35 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 · 18 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090258-001 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 A090258-002 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 A090258-003 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 A090258-004 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 4 matching rows.
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 5 · 164 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 2026-02-19 14:30 UTC 2026-02 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 164 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10135-696-12 Alendronate 3 in 1 CARTON TABLET 3 1 10135-696-12 Alendronate 4 in 1 BLISTER PACK TABLET 4 1 10135-696-44 Alendronate 1 in 1 CARTON TABLET 1 1 10135-696-44 Alendronate 4 in 1 BLISTER PACK TABLET 4 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-696 ALENDRONATE (ALENDRONATE SODIUM) TABLET [MARLEX PHARMACEUTICALS INC] 1 Legacy NDC, 4 package rows 20200410_c1e61b54-287f-47ed-9192-e3c98ecb2e06.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 · 2 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 10135-696-12 10135069612 3 BLISTER PACK in 1 CARTON (10135-696-12) > 4 TABLET in 1 BLISTER PACK 3 blister pack 2020-03-01 0000-00-00 No No Current