Actonel

Product NDC: 0430-0478
Requested package NDC: 0430-0478-02
11-digit product format: 004300478
Labeler code: 0430
Product ID: 0430-0478_a874a4b5-3deb-40b1-9cb8-d80c3fca4401
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risedronate Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA020835
Marketing category: NDA
Marketing start: 2008-04-22
Substance: RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength: 129; 21 mg/1; mg/1
Pharmacologic classes: Bisphosphonate [EPC], Bisphosphonate [EPC], Diphosphonates [CS], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0430-0478	0430-0478-02	D	Discontinued by firm		2026-08-17

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0430-0478	0430-0478-02	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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.

Application-product, TE code table
Application-product	TE code
N020835-003	AB
N020835-005	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020835-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020835-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020835-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020835-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020835-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020835-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020835-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020835-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020835-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020835-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020835-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020835-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020835-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020835-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020835-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020835-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020835-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020835-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020835-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020835-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020835-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020835-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020835-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020835-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020835-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020835-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020835-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020835-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020835-002	AB	1	`4b0b4de00fa7…`

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	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Actonel
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISEDRONATE SODIUM HEMIPENTAHYDRATE	129 mg/1
RISEDRONATE SODIUM MONOHYDRATE	21 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F67L43UT5C	Internal UNII lookup
HU2YAQ274O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 16 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905024	Internal RxNorm lookup
905026	Internal RxNorm lookup
905028	Internal RxNorm lookup
905030	Internal RxNorm lookup
905032	Internal RxNorm lookup
905034	Internal RxNorm lookup
905041	Internal RxNorm lookup
905043	Internal RxNorm lookup
905083	Internal RxNorm lookup
905084	Internal RxNorm lookup
905086	Internal RxNorm lookup
905087	Internal RxNorm lookup
905092	Internal RxNorm lookup
905093	Internal RxNorm lookup
905100	Internal RxNorm lookup
905101	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
24ed00e0-25e2-49a8-97fc-66c1b417dc0b	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dc99ed49-98e9-42a6-aef0-a6dc585a6a09	Product name	4	20191002
a51ae56f-109a-47a0-9ce1-2b825be8c01b	Product name	5	20190614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0430-0478-01	Actonel	1 in 1 DOSE PACK	TABLET, FILM COATED	1		31
0430-0478-02	Actonel	3 in 1 DOSE PACK	TABLET, FILM COATED	3		31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0430-0478-01	EA - Each	0430-0478	1d59b9ee-8e61-4194-a6c6-92ff2853af1f	1	2012-07-24
0430-0478-02	EA - Each	0430-0478	3e286149-6d62-42b4-9e1c-efbc7fc83f5d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RISEDRONATE SODIUM HEMI-PENTAHYDRATE	ACTIVE INGREDIENT	HU2YAQ274O	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
RISEDRONATE SODIUM MONOHYDRATE	ACTIVE INGREDIENT	F67L43UT5C	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
RISEDRONIC ACID	ACTIVE MOIETY	KM2Z91756Z	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [WARNER CHILCOTT (US), LLC]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0430-0478	ACTONEL (RISEDRONATE SODIUM) TABLET, FILM COATED [ALLERGAN, INC.]	27	Current NDC, Legacy NDC, 2 package rows	20240912_24ed00e0-25e2-49a8-97fc-66c1b417dc0b.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	f715718a-407d-4e2a-9834-74a8f1361d03	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020835 application number: NDA020835
Actonel	RISEDRONATE SODIUM	Allergan, Inc.	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020835 application number: NDA020835 ndc (package): 0430-0478-02 ndc (product): 0430-0478 ndc11 (package): 00430047802

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F67L43UT5C	RISEDRONATE SODIUM MONOHYDRATE	353228-19-0	RISEDRONATE SODIUM MONOHYDRATE
OFG5EXG60L	RISEDRONATE SODIUM	115436-72-1	Risedronate Sodium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905101	{12 (risedronate sodium 35 MG Oral Tablet [Actonel]) } Pack [Actonel 35 12-Week]	BPCK	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905087	{2 (risedronate sodium 75 MG Oral Tablet [Actonel]) } Pack [Actonel 75]	BPCK	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905093	{4 (risedronate sodium 35 MG Oral Tablet [Actonel]) } Pack [Actonel 35 4-Week]	BPCK	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905100	{12 (risedronate sodium 35 MG Oral Tablet) } Pack	GPCK	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905084	{2 (risedronate sodium 75 MG Oral Tablet) } Pack	GPCK	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905092	{4 (risedronate sodium 35 MG Oral Tablet) } Pack	GPCK	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905030	Actonel 150 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905034	Actonel 30 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905101	Actonel 35 12-Week Once Weekly Dosepack	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905093	Actonel 35 4-Week Once Weekly Dosepack	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905026	Actonel 35 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905043	Actonel 5 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905087	Actonel 75 Dosepack	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905086	Actonel 75 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905028	risedronate sodium 150 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905032	risedronate sodium 30 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905100	risedronate sodium 35 MG (12) Oral Tablet Pack	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905092	risedronate sodium 35 MG (4) Oral Tablet Pack	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905024	risedronate sodium 35 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905041	risedronate sodium 5 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905083	risedronate sodium 75 MG Oral Tablet	PSN	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905030	risedronate sodium 150 MG Oral Tablet [Actonel]	SBD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905034	risedronate sodium 30 MG Oral Tablet [Actonel]	SBD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905026	risedronate sodium 35 MG Oral Tablet [Actonel]	SBD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905043	risedronate sodium 5 MG Oral Tablet [Actonel]	SBD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905086	risedronate sodium 75 MG Oral Tablet [Actonel]	SBD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905028	risedronate sodium 150 MG Oral Tablet	SCD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905032	risedronate sodium 30 MG Oral Tablet	SCD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905024	risedronate sodium 35 MG Oral Tablet	SCD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905041	risedronate sodium 5 MG Oral Tablet	SCD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905083	risedronate sodium 75 MG Oral Tablet	SCD	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905030	Actonel 150 MG Oral Tablet	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905034	Actonel 30 MG Oral Tablet	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905101	Actonel 35 12-Week Once Weekly Dosepack	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905093	Actonel 35 4-Week Once Weekly Dosepack	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905026	Actonel 35 MG Oral Tablet	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905043	Actonel 5 MG Oral Tablet	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905087	Actonel 75 Dosepack	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905086	Actonel 75 MG Oral Tablet	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905084	Risedronate 75 MG Oral Tablet 2 Count Pack	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905100	risedronate sodium 35 MG Oral Tablet, 12 Week Pack	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31
905092	risedronate sodium 35 MG Oral Tablet, 4 Week Pack	SY	24ed00e0-25e2-49a8-97fc-66c1b417dc0b	31

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0430-0478-02	00430047802	3 TABLET, FILM COATED in 1 DOSE PACK (0430-0478-02)	2008-04-22	0000-00-00	No	No	Current