Home NDC 55111-575 Ibandronate sodium
Product NDC 55111-575
11-digit product format 551110575
Labeler code 55111
Product ID 55111-575_eeeb1802-6fe6-ebb0-2df8-98b42385b89f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ibandronate sodium
Dosage form TABLET
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA078997
Marketing category ANDA
Marketing start 2012-06-21
Substance IBANDRONATE SODIUM
Active strength 150 mg/1
Pharmacologic classes Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A078997-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078997-001 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 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB 2012-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078997-001 IBANDRONATE SODIUM EQ 150MG BASE TABLET / ORAL AB RS 2012-04-30 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 150 mg/1
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 904932 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 55111-575-03 Ibandronate sodium 3 in 1 CARTON TABLET 3 22 55111-575-11 Ibandronate sodium 1 in 1 BLISTER PACK TABLET 1 22 55111-575-13 Ibandronate sodium 3 in 1 BLISTER PACK TABLET 3 22 55111-575-43 Ibandronate sodium 1 in 1 CARTON TABLET 1 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-575 IBANDRONATE SODIUM TABLET [DR. REDDY'S LABORATORIES LIMITED] 21 Current NDC, Legacy NDC, 4 package rows 20230531_f94d9c49-245a-8081-42c4-785113fce498.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55111-575-03 55111057503 3 BLISTER PACK in 1 CARTON (55111-575-03) / 1 TABLET in 1 BLISTER PACK (55111-575-11) 3 blister pack 2012-06-21 0000-00-00 No No Current 55111-575-11 55111057511 1 in 1 BLISTER PACK Historical 55111-575-13 55111057513 3 in 1 BLISTER PACK Historical 55111-575-43 55111057543 1 BLISTER PACK in 1 CARTON (55111-575-43) / 3 TABLET in 1 BLISTER PACK (55111-575-13) 1 blister pack 2021-11-20 0000-00-00 No No Current