Home NDC 51224-301-10 Alendronate Sodium
Product NDC 51224-301
Requested package NDC 51224-301-10
11-digit product format 512240301
Labeler code 51224
Product ID 51224-301_640b0622-236e-46bd-8b46-1b1083719826
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Alendronate Sodium
Dosage form SOLUTION
Route ORAL
Labeler TAGI Pharma, Inc.
Application ANDA090520
Marketing category ANDA
Marketing start 2013-02-25
Marketing end 2022-04-30
Substance ALENDRONATE SODIUM
Active strength 70 mg/75mL
Pharmacologic classes Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 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…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090520-001 ALENDRONATE SODIUM ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090520-001 AA
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 2 · 41 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 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL AA RS 2013-02-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090520-001 ALENDRONATE SODIUM EQ 70MG BASE/75ML SOLUTION / ORAL RS 2013-02-25 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Socrata Ingredients# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51224-301-10 51224030110 4 BOTTLE, UNIT-DOSE in 1 CARTON (51224-301-10) > 75 mL in 1 BOTTLE, UNIT-DOSE 2013-02-25 2022-04-30 No No Current