Home NDC 33342-109 Risedronate Sodium
Product NDC 33342-109
11-digit product format 333420109
Labeler code 33342
Product ID 33342-109_56e83e0f-83f7-4039-a9b2-0d5ae251e2b1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risedronate Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203533
Marketing category ANDA
Marketing start 2015-12-09
Substance RISEDRONATE SODIUM
Active strength 35 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203533-001 RISEDRONATE SODIUM RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 A203533-002 RISEDRONATE SODIUM RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 A203533-003 RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 4 · 126 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 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203533-002 RISEDRONATE SODIUM 30MG TABLET / ORAL AB 2015-12-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203533-003 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2016-11-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203533-001 RISEDRONATE SODIUM 5MG TABLET / ORAL AB 2015-12-09 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 observed states.
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 35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination OFG5EXG60L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905024 Internal RxNorm lookup 905032 Internal RxNorm lookup 905041 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 33342-109-37 Risedronate Sodium 4 in 1 BLISTER PACK TABLET, FILM COATED 4 9 33342-109-37 Risedronate Sodium 1 in 1 CARTON TABLET, FILM COATED 1 9 33342-109-50 Risedronate Sodium 4 in 1 BLISTER PACK TABLET, FILM COATED 4 9 33342-109-50 Risedronate Sodium 3 in 1 CARTON TABLET, FILM COATED 3 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-109 RISEDRONATE SODIUM TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 7 Current NDC, Legacy NDC, 4 package rows 20230802_62aff8d6-a2f7-4c7e-a102-c70105ac3792.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 33342-109-37 33342010937 1 BLISTER PACK in 1 CARTON (33342-109-37) / 4 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2015-12-09 0000-00-00 No No Current 33342-109-50 33342010950 3 BLISTER PACK in 1 CARTON (33342-109-50) / 4 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2015-12-09 0000-00-00 No No Current