Home NDC 0149-0478 ACTONEL
Product NDC 0149-0478
11-digit product format 001490478
Labeler code 0149
Product ID 0149-0478_05985725-417c-44f4-9e38-4fed7cdfdaad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name RISEDRONATE SODIUM
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Warner Chilcott Pharmaceuticals Inc.
Application NDA020835
Marketing category NDA
Marketing start 2008-04-22
Marketing end 0000-00-00
Substance RISEDRONATE SODIUM
Active strength 150 mg/1
Pharmacologic classes Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag E
Listing certified through 2017-12-31
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 2 · 75 matching rows.
View current auxiliary records. · View the auxiliary file history.
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N020835-004 ACTONEL RISEDRONATE SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 N020835-005 ACTONEL RISEDRONATE SODIUM 150MG TABLET / ORAL AB RLD, RS 2008-04-22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 Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded RISEDRONATE SODIUM ACTIVE INGREDIENT OFG5EXG60L ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 risedronic acid ACTIVE MOIETY KM2Z91756Z ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 HYPROMELLOSE INACTIVE INGREDIENT 3NXW29V3WO ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT PHARMACEUTICALS INC.] 10 RISEDRONATE SODIUM ACTIVE INGREDIENT OFG5EXG60L ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 RISEDRONIC ACID ACTIVE MOIETY KM2Z91756Z ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYDROXYPROPYL CELLULOSE INACTIVE INGREDIENT RFW2ET671P ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] 2
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#