Home NDC 47781-103 IBANDRONATE SODIUM
Product NDC 47781-103
11-digit product format 477810103
Labeler code 47781
Product ID 47781-103_86be42bb-38fd-8b9d-e5ee-43d0703d9fd0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IBANDRONATE SODIUM
Dosage form TABLET
Route ORAL
Labeler Alvogen Inc.
Application ANDA078998
Marketing category ANDA
Marketing start 2014-05-01
Marketing end 0000-00-00
Substance IBANDRONATE SODIUM
Active strength 150 mg/1
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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 47781-103 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 47781-103 47781-103-33 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 47781-103 47781-103-21 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A078998-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078998-001 AB
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 · 42 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 2026-08-18 06:07:40 2026-07 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078998-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-03-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 47781-103 IBANDRONATE SODIUM TABLET [ALVOGEN INC.] 14 Legacy NDC 20241011_acbc54fc-4248-416f-849c-2cd3bed0a843.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 47781-103-21 47781010321 1 BLISTER PACK in 1 CARTON (47781-103-21) > 3 TABLET in 1 BLISTER PACK 1 blister pack 2019-12-18 0000-00-00 No No Current 47781-103-33 47781010333 3 BLISTER PACK in 1 BOX (47781-103-33) > 1 TABLET in 1 BLISTER PACK (47781-103-07) 3 blister pack 2014-05-01 0000-00-00 No No Current