Home NDC 10135-718 Alendronate
Product NDC 10135-718
11-digit product format 101350718
Labeler code 10135
Product ID 10135-718_3e74abef-2742-2bbe-e063-6394a90a12cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alendronate sodium tablet
Dosage form TABLET
Route ORAL
Labeler Marlex Pharmaceuticals, Inc.
Application ANDA090258
Marketing category ANDA
Marketing start 2020-12-01
Substance ALENDRONATE SODIUM
Active strength 35 mg/1
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base Alendronate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALENDRONATE SODIUM 35 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 904396 Internal RxNorm lookup 904431 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 10135-718-12 Alendronate 3 in 1 CARTON TABLET 3 6 10135-718-12 Alendronate 4 in 1 BLISTER PACK TABLET 4 6 10135-718-44 Alendronate 4 in 1 BLISTER PACK TABLET 4 6 10135-718-44 Alendronate 1 in 1 CARTON TABLET 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-718 ALENDRONATE (ALENDRONATE SODIUM TABLET) TABLET [MARLEX PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 4 package rows 20240915_b63421af-ec03-1de7-e053-2a95a90abec6.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 10135-718-12 10135071812 3 BLISTER PACK in 1 CARTON (10135-718-12) / 4 TABLET in 1 BLISTER PACK 3 blister pack 2020-12-01 0000-00-00 No No Current 10135-718-44 10135071844 1 BLISTER PACK in 1 CARTON (10135-718-44) / 4 TABLET in 1 BLISTER PACK 1 blister pack 2020-12-01 0000-00-00 No No Current