Home NDC 10135-719 Alendronate
Product NDC 10135-719
11-digit product format 101350719
Labeler code 10135
Product ID 10135-719_5dfb197c-2666-d326-e063-6294a90a9fde
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 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 · 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 · 176 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 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 c2088c7a36db…2026-10-15 13:18:30 2026-09 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 c2088c7a36db…2026-09-14 22:38:34 2026-08 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 84e616aacf4f…2026-09-14 22:38:34 2026-08 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 84e616aacf4f…2026-08-18 06:07:40 2026-07 A090258-001 ALENDRONATE SODIUM EQ 5MG BASE TABLET / ORAL AB 2009-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090258-002 ALENDRONATE SODIUM EQ 10MG BASE TABLET / ORAL AB 2009-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090258-003 ALENDRONATE SODIUM EQ 35MG BASE TABLET / ORAL AB 2009-09-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090258-004 ALENDRONATE SODIUM EQ 70MG BASE TABLET / ORAL AB 2009-09-24 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 5 · 176 observed states.
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 Alendronate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALENDRONATE SODIUM 70 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10135-719 ALENDRONATE (ALENDRONATE SODIUM TABLET) TABLET [MARLEX PHARMACEUTICALS, INC.] 5 Current NDC, Legacy NDC, 6 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Alendronate ALENDRONATE SODIUM Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd. a24fd39c-34a7-4de2-9439-781e612189ca 2025-12-16 Warnings, Adverse reactions Exact identifier application applno (ANDA): 090258 application number: ANDA090258
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 10135-719-12 10135071912 3 BLISTER PACK in 1 CARTON (10135-719-12) / 4 TABLET in 1 BLISTER PACK 3 blister pack 2020-12-01 0000-00-00 No No Current 10135-719-20 10135071920 2 BLISTER PACK in 1 CARTON (10135-719-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2020-12-01 0000-00-00 No No Current 10135-719-44 10135071944 1 BLISTER PACK in 1 CARTON (10135-719-44) / 4 TABLET in 1 BLISTER PACK 1 blister pack 2020-12-01 0000-00-00 No No Current