Home NDC 0591-3876 Risedronate Sodium
Product NDC 0591-3876
11-digit product format 005913876
Labeler code 0591
Product ID 0591-3876_cbad3736-ad79-475b-b35d-b9fce4923650
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risedronate sodium
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA022560
Marketing category NDA
Marketing start 2010-12-01
Marketing end 0000-00-00
Substance RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength 30 mg/1; mg/1
Pharmacologic classes Bisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag No
Listing certified through 2020-12-31
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0591-3876-04 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0591-3876-04 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0591-3876-04 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0591-3876-04 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0591-3876-04 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0591-3876-04 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0591-3876-04 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0591-3876-04 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0591-3876-04 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0591-3876-04 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0591-3876-04 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0591-3876-04 557ba5c1ecfa…9c80585c8c6e…
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 N022560-001 ATELVIA RISEDRONATE SODIUM 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022560-001 AB
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022560-001 8246989 2026-01-16 Drug product 2012-08-28 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01
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 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 126 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 1e350fbaab3a…
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.