Home NDC 51224-008 IBANDRONATE SODIUM
Product NDC 51224-008
11-digit product format 512240008
Labeler code 51224
Product ID 51224-008_4d64c479-f90c-40a5-bfaf-c92f884b5133
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibandronate Sodium
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler TAGI Pharma, Inc.
Application ANDA204329
Marketing category ANDA
Marketing start 2022-06-30
Marketing end 0000-00-00
Substance IBANDRONATE SODIUM
Active strength 3 mg/3mL
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2023-12-31
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, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 51224-008-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 51224-008-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 51224-008-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 51224-008-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 51224-008-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 51224-008-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 51224-008-01 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 51224-008-01 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 51224-008-01 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A204329-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16
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.
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 2026-08-18 06:07:40 2026-07 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2021-06-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A204329-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2021-06-16 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2021-12-28 21:50 UTC 2021-12 A204329-001 AP 1 782e0a99824c…
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51224-008 IBANDRONATE SODIUM INJECTION, SOLUTION [TAGI PHARMA, INC.] 11 Legacy NDC 20250101_57970375-1b7f-43ec-b1f1-43b03168ac4a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 51224-008-01 51224000801 1 SYRINGE, GLASS in 1 CARTON (51224-008-01) > 3 mL in 1 SYRINGE, GLASS 2022-06-30 0000-00-00 No No Current