Home NDC 60723-205 Alendronate
Product NDC 60723-205
11-digit product format 607230205
Labeler code 60723
Product ID 60723-205_460d461d-4807-2ed0-e063-6394a90aad4a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ALENDRONATE SODIUM
Dosage form TABLET
Route ORAL
Labeler Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
Application ANDA090258
Marketing category ANDA
Marketing start 2017-12-05
Substance ALENDRONATE SODIUM
Active strength 70 mg/1
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 2 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 60723-205 UNFINISHED Active or certified unfinished drug listing 2026-08-10 unfinished package package 60723-205 60723-205-01 UNFINISHED Active or certified unfinished drug listing 2026-08-10
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 unfinished product product a6255e0c9aa5…a0211a219f2e…2025-12-14 21:27 UTC · source 2025-12-05 unfinished package package 60723-205-01 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 unfinished product product 1d862106b807…00c93037cd84…2025-08-26 23:59 UTC · source 2025-08-26 unfinished package package 60723-205-01 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 unfinished product product 390b4c401c3f…2c692c2daee3…2025-05-15 14:59 UTC · source 2025-05-14 unfinished package package 60723-205-01 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 unfinished product product e30019b0c005…a3f0b14938b7…2025-04-01 07:37 UTC · source 2025-03-31 unfinished package package 60723-205-01 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 unfinished product product bbbc9f937eca…946b9c97cf81…2025-03-01 13:19 UTC · source 2025-02-28 unfinished package package 60723-205-01 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 unfinished product product f268b84574a6…26285f5ac5df…2025-02-27 05:24 UTC · source 2025-02-26 unfinished package package 60723-205-01 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 unfinished product product f764e8902f78…92046438deef…2025-02-01 13:13 UTC · source 2025-01-31 unfinished package package 60723-205-01 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 unfinished product product 68b1e3bced9e…98a755eb8bc6…2025-01-20 13:05 UTC · source 2025-01-17 unfinished package package 60723-205-01 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 unfinished product product 05c55d027831…ca05dca9dc4c…2024-11-29 20:42 UTC · source 2024-11-29 unfinished package package 60723-205-01 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 unfinished product product 48b4f40e6753…c7c7a00d2afa…2024-11-09 02:36 UTC · source 2024-11-08 unfinished package package 60723-205-01 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 unfinished product product 27f29a85d7e4…1372111e901f…2024-10-09 02:27 UTC · source 2024-10-08 unfinished package package 60723-205-01 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 unfinished product product 8d62ce987f31…9fe9ef23e30d…2024-07-10 04:00 UTC · source 2024-07-09 unfinished package package 60723-205-01 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished product product d1e113ab4d42…063ee3eb0a1d…2024-05-28 21:11 UTC · source 2024-05-28 unfinished package package 60723-205-01 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 unfinished product product 50b4072663b7…eae3003ed65e…2024-05-15 03:51 UTC · source 2024-05-14 unfinished package package 60723-205-01 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 unfinished product product 906f6e251498…bf70b80e44f0…2022-04-09 23:13 UTC · source 2022-04-08 unfinished package package 60723-205-01 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 unfinished product product 6db9cb8d1e19…3449e1ec5b70…2021-12-27 23:28 UTC · source 2021-12-27 unfinished package package 60723-205-01 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 unfinished product product 8fc7167e32ce…e96bbc724034…2021-02-18 23:40 UTC · source 2021-02-18 unfinished package package 60723-205-01 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 unfinished product product 4184dd79f89f…545327b3e20f…2020-12-18 03:04 UTC · source 2020-12-17 unfinished package package 60723-205-01 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished product product 4bd3596a7b87…5c64c6f6865f…2020-06-10 20:45 UTC · source 2020-06-10 unfinished package package 60723-205-01 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 unfinished product product 263afe128892…91768de4ddbe…2019-12-08 06:16 UTC · source 2019-12-05 unfinished package package 60723-205-01 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 unfinished product product 5b2001dcd8f5…54b53d4dc9e4…2019-06-01 22:24 UTC · source 2019-05-30 unfinished package package 60723-205-01 5b2001dcd8f5…54b53d4dc9e4…
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 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 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60723-205 ALENDRONATE (ALENDRONATE SODIUM) TABLET [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.] 26 Current NDC, Legacy NDC, 6 package rows 20241123_a24fd39c-34a7-4de2-9439-781e612189ca.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 60723-205-01 60723020501 1 BAG in 1 CASE (60723-205-01) / 40000 TABLET in 1 BAG 1 bag 25-JAN-18 Current 60723-205-31 60723020531 1 BLISTER PACK in 1 CARTON (60723-205-31) / 4 TABLET in 1 BLISTER PACK 1 blister pack 2017-12-05 0000-00-00 No No Current 60723-205-32 60723020532 3 BLISTER PACK in 1 CARTON (60723-205-32) / 4 TABLET in 1 BLISTER PACK 3 blister pack 2017-12-05 0000-00-00 No No Current 60723-205-33 60723020533 2 BLISTER PACK in 1 CARTON (60723-205-33) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2017-12-05 0000-00-00 No No Current