Home NDC 59762-0407-4 Risedronate Sodium
Product NDC 59762-0407
Requested package NDC 59762-0407-4
11-digit product format 597620407
Labeler code 59762
Product ID 59762-0407_b7e3ea01-4634-467a-b087-3d52ef7af465
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risedronate sodium
Dosage form TABLET, DELAYED RELEASE
Route ORAL
Labeler Mylan Pharmaceuticals, Inc.
Application NDA022560
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-03-02
Substance RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength 30.1; 4.9 mg/1; mg/1
Pharmacologic classes Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], 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 43 .
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 · 43 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 2026-09-14 22:38:34 2026-08 N022560-001 ATELVIA 35MG TABLET, DELAYED RELEASE / ORAL AB RLD, RS 2010-10-08 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Observed Orange Book patent history# Patent history page 1 of 4 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022560-001 8246989 2026-01-16 Drug product 2012-08-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022560-001 7645459 2028-01-09 U-662 Drug product 2010-11-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022560-001 7645460 2028-01-09 U-662 Drug product 2010-11-01 84e616aacf4f…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…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Risedronate Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISEDRONATE SODIUM HEMIPENTAHYDRATE 30.1 mg/1 RISEDRONATE SODIUM MONOHYDRATE 4.9 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HU2YAQ274O Internal UNII lookup F67L43UT5C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020064 Internal RxNorm lookup 1020065 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 59762-0407-4 Risedronate Sodium 4 in 1 DOSE PACK TABLET, DELAYED RELEASE 4 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0407 RISEDRONATE SODIUM TABLET, DELAYED RELEASE [GREENSTONE LLC] 5 Current NDC, Legacy NDC, 1 package rows 20240119_c89430be-15f1-4b8b-ab7e-738de716ee7d.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 Marketing start Marketing end Sample Exclude flag Status 59762-0407-4 59762040704 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (59762-0407-4) 2018-03-02 0000-00-00 No No Current