Home NDC 60505-6097 Ibandronate Sodium
Product NDC 60505-6097
11-digit product format 605056097
Labeler code 60505
Product ID 60505-6097_63d90e35-b379-2511-e5fd-b75c1d1d5dde
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ibandronate sodium
Dosage form INJECTION
Route INTRAVENOUS
Labeler Apotex Corp.
Application ANDA204222
Marketing category ANDA
Marketing start 2016-01-13
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 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 A204222-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204222-001 AP
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 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 904952 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6097-0 Ibandronate Sodium 3 mL in 1 SYRINGE, GLASS INJECTION 3 10 60505-6097-0 Ibandronate Sodium 1 in 1 CARTON INJECTION 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6097 IBANDRONATE SODIUM INJECTION [APOTEX CORP.] 6 Current NDC, Legacy NDC, 2 package rows 20241004_9fad4982-95af-d711-f50a-867311835143.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 Marketing end Sample Exclude flag Status 60505-6097-0 60505609700 1 SYRINGE, GLASS in 1 CARTON (60505-6097-0) / 3 mL in 1 SYRINGE, GLASS 2016-01-13 0000-00-00 No No Current