Home NDC 0591-2102 risedronate sodium
Product NDC 0591-2102
11-digit product format 005912102
Labeler code 0591
Product ID 0591-2102_77563bfa-9732-4d38-b5ca-f11f1a5fb2ed
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name risedronate sodium
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application NDA020835
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-06-27
Marketing end 2020-07-31
Substance RISEDRONATE SODIUM HEMI-PENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength 4 mg/1; mg/1
Pharmacologic classes Bisphosphonate [EPC],Diphosphonates [CS],Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 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 0591-2102-30 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020835-001 ACTONEL RISEDRONATE SODIUM 30MG TABLET / ORAL RLD 1998-03-27 N020835-002 ACTONEL RISEDRONATE SODIUM 5MG TABLET / ORAL RLD 2000-04-14 N020835-003 ACTONEL RISEDRONATE SODIUM 35MG TABLET / ORAL AB RLD, RS 2002-05-25 N020835-004 ACTONEL RISEDRONATE SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 N020835-005 ACTONEL RISEDRONATE SODIUM 150MG TABLET / ORAL AB RLD, RS 2008-04-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 6 · 210 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 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020835-004 ACTONEL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 112 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 112 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020835-005 7192938 2023-05-06 U-353 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020835-005 7718634 2023-05-06 U-662 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020835-005 7192938*PED 2023-11-06 Pediatric extension 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020835-005 7718634*PED 2023-11-06 Pediatric extension 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020835-005 7192938 2023-05-06 U-353 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020835-005 7718634 2023-05-06 U-662 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020835-005 7192938*PED 2023-11-06 Pediatric extension 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020835-005 7718634*PED 2023-11-06 Pediatric extension 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020835-005 7192938 2023-05-06 U-353 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020835-005 7718634 2023-05-06 U-662 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020835-005 7192938*PED 2023-11-06 Pediatric extension 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020835-005 7718634*PED 2023-11-06 Pediatric extension 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020835-003 5994329*PED 2019-01-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-003 6015801*PED 2019-01-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-003 6432932*PED 2019-01-17 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-003 6465443*PED 2019-02-14 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-005 7192938 2023-05-06 U-353 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-005 7718634 2023-05-06 U-662 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-005 7192938*PED 2023-11-06 Pediatric extension 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020835-005 7718634*PED 2023-11-06 Pediatric extension 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020835-005 7192938 2023-05-06 U-353 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020835-005 7718634 2023-05-06 U-662 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020835-005 7192938*PED 2023-11-06 Pediatric extension bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020835-005 7718634*PED 2023-11-06 Pediatric extension bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020835-005 7192938 2023-05-06 U-353 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020835-005 7718634 2023-05-06 U-662 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020835-005 7192938*PED 2023-11-06 Pediatric extension 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020835-005 7718634*PED 2023-11-06 Pediatric extension 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020835-005 7192938 2023-05-06 U-353 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020835-005 7718634 2023-05-06 U-662 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020835-005 7192938*PED 2023-11-06 Pediatric extension 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020835-005 7718634*PED 2023-11-06 Pediatric extension 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020835-005 7192938 2023-05-06 U-353 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020835-005 7718634 2023-05-06 U-662 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020835-005 7192938*PED 2023-11-06 Pediatric extension 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N020835-005 7718634*PED 2023-11-06 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020835-005 7192938 2023-05-06 U-353 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020835-005 7718634 2023-05-06 U-662 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020835-005 7192938*PED 2023-11-06 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N020835-005 7718634*PED 2023-11-06 Pediatric extension 8869cabd3fbd…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISEDRONATE SODIUM HEMI-PENTAHYDRATE ACTIVE INGREDIENT HU2YAQ274O RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 RISEDRONATE SODIUM MONOHYDRATE ACTIVE INGREDIENT F67L43UT5C RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 RISEDRONIC ACID ACTIVE MOIETY KM2Z91756Z RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RISEDRONATE SODIUM TABLET, FILM COATED [ACTAVIS PHARMA, INC.] 1
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.