Home DailyMed 3e286149-6d62-42b4-9e1c-efbc7fc83f5d National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 01:34:37 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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N020835-004 ACTONEL RISEDRONATE SODIUM 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2007-04-16 N020835-005 ACTONEL RISEDRONATE SODIUM 150MG TABLET / ORAL AB RLD, RS 2008-04-22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 · 215 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 2026-09-14 22:38:34 2026-08 N020835-001 ACTONEL 30MG TABLET / ORAL RLD 1998-03-27 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020835-002 ACTONEL 5MG TABLET / ORAL RLD 2000-04-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020835-003 ACTONEL 35MG TABLET / ORAL AB RLD, RS 2002-05-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020835-005 ACTONEL 150MG TABLET / ORAL AB RLD, RS 2008-04-22 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 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…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.