Home NDC 60505-3097 Risedronate Sodium
Product NDC 60505-3097
11-digit product format 605053097
Labeler code 60505
Product ID 60505-3097_03750616-5c88-729a-215e-3d796f8ba6a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Risedronate Sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA090877
Marketing category ANDA
Marketing start 2014-06-11
Substance RISEDRONATE SODIUM
Active strength 150 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 A090877-001 RISEDRONATE SODIUM RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 A090877-002 RISEDRONATE SODIUM RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 A090877-003 RISEDRONATE SODIUM RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10
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 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090877-002 RISEDRONATE SODIUM 75MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090877-003 RISEDRONATE SODIUM 150MG TABLET / ORAL AB 2014-06-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090877-001 RISEDRONATE SODIUM 35MG TABLET / ORAL AB 2015-11-30 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 150 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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 905024 Internal RxNorm lookup 905028 Internal RxNorm lookup 905083 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 60505-3097-2 Risedronate Sodium 1 in 1 CARTON TABLET, FILM COATED 1 15 60505-3097-2 Risedronate Sodium 1 in 1 BLISTER PACK TABLET, FILM COATED 1 15 60505-3097-4 Risedronate Sodium 1 in 1 CARTON TABLET, FILM COATED 1 15 60505-3097-4 Risedronate Sodium 3 in 1 BLISTER PACK TABLET, FILM COATED 3 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISEDRONATE SODIUM ANHYDROUS ACTIVE INGREDIENT OFG5EXG60L RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 RISEDRONIC ACID ACTIVE MOIETY KM2Z91756Z RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 Crospovidone INACTIVE INGREDIENT 68401960MK RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 SODIUM PHOSPHATE, DIBASIC INACTIVE INGREDIENT GR686LBA74 RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE INACTIVE INGREDIENT 593YOG76RN RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-3097 RISEDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP.] 14 Current NDC, Legacy NDC, 4 package rows 20250411_b90f2e5b-10b8-29a7-0360-31bd0dae0ec2.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 60505-3097-2 60505309702 1 BLISTER PACK in 1 CARTON (60505-3097-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2014-06-11 0000-00-00 No No Current 60505-3097-4 60505309704 1 BLISTER PACK in 1 CARTON (60505-3097-4) / 3 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2014-06-11 0000-00-00 No No Current