Home NDC 62756-218-40 IBANDRONATE SODIUM
Product NDC 62756-218
Requested package NDC 62756-218-40
11-digit product format 627560218
Labeler code 62756
Product ID 62756-218_61378ee8-cc2f-4f55-954b-4eb55e975f5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name IBANDRONATE SODIUM
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA090853
Marketing category ANDA
Marketing start 2014-02-15
Substance IBANDRONATE SODIUM
Active strength 3 mg/3mL
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 21 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 9bebd1f3094a…5416666fcb17…
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 A090853-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14
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 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS 2014-02-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090853-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2014-02-14 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base IBANDRONATE SODIUM
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBANDRONATE SODIUM 3 mg/3mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J12U072QL0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 904955 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62756-218-40 IBANDRONATE SODIUM 1 in 1 CARTON INJECTION, SOLUTION 1 6 62756-218-40 IBANDRONATE SODIUM 3 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 3 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-218 IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.] 5 Current NDC, Legacy NDC, 2 package rows 20181026_be514be6-727a-4d6c-993b-52144f8e6de8.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 62756-218-40 62756021840 1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) / 3 mL in 1 VIAL, SINGLE-DOSE 2014-02-15 No No Current