Home NDC 60723-041 Risedronate Sodium
Product NDC 60723-041
11-digit product format 607230041
Labeler code 60723
Product ID 60723-041_460cdef1-681b-7ae4-e063-6294a90a1d55
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risedronate Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Hangzhou Minsheng Binjiang Pharmaceutical CO., Ltd
Application ANDA207516
Marketing category ANDA
Marketing start 2019-04-01
Substance RISEDRONATE SODIUM HEMI-PENTAHYDRATE
Active strength 35 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 A207516-001 RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15
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 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2019-02-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207516-001 RISEDRONATE SODIUM 35MG TABLET / ORAL 2019-02-15 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2019-07-19 19:46 UTC 2019-07 A207516-001 AB 1 ea99ee380514…
Additional Listing Data#
Finished product Yes
Brand name base Risedronate Sodium
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength RISEDRONATE SODIUM HEMI-PENTAHYDRATE 35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HU2YAQ274O Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905024 Internal RxNorm lookup 905092 Internal RxNorm lookup 905100 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 60723-041-01 Risedronate Sodium 4 in 1 BLISTER PACK TABLET, FILM COATED 4 15 60723-041-04 Risedronate Sodium 1 in 1 CARTON TABLET, FILM COATED 1 15 60723-041-12 Risedronate Sodium 3 in 1 CARTON TABLET, FILM COATED 3 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60723-041 RISEDRONATE SODIUM TABLET, FILM COATED [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD] 14 Current NDC, Legacy NDC, 3 package rows 20241123_d60a56cb-ef49-4447-9043-7b6879a20d75.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 Units Marketing start Marketing end Sample Exclude flag Status 60723-041-01 60723004101 4 in 1 BLISTER PACK Historical 60723-041-04 60723004104 1 BLISTER PACK in 1 CARTON (60723-041-04) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01) 1 blister pack 2019-04-01 0000-00-00 No No Current 60723-041-12 60723004112 3 BLISTER PACK in 1 CARTON (60723-041-12) / 4 TABLET, FILM COATED in 1 BLISTER PACK (60723-041-01) 3 blister pack 2019-04-01 0000-00-00 No No Current