Risedronate Sodium

Product NDC: 65862-519
Requested package NDC: 65862-519-26
11-digit product format: 658620519
Labeler code: 65862
Product ID: 65862-519_9488209f-f3ad-4726-be89-f6a7e59e6885
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Risedronate Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA200296
Marketing category: ANDA
Marketing start: 2015-11-30
Substance: RISEDRONATE SODIUM
Active strength: 35 mg/1
Pharmacologic classes: Bisphosphonate [EPC], 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
unfinished package	package	65862-519	65862-519-26	UNFINISHED	Active or certified unfinished drug listing		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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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	Approval date
A200296-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30
A200296-002	RISEDRONATE SODIUM	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30
A200296-003	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A200296-001	AB
A200296-002	AB
A200296-003	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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200296-002	RISEDRONATE SODIUM	30MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200296-003	RISEDRONATE SODIUM	35MG	TABLET / ORAL	AB	2015-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200296-001	RISEDRONATE SODIUM	5MG	TABLET / ORAL	AB	2015-11-30	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A200296-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200296-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200296-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200296-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200296-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200296-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200296-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200296-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200296-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200296-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200296-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200296-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200296-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200296-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200296-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200296-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200296-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200296-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200296-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200296-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200296-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200296-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200296-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200296-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200296-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200296-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200296-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200296-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200296-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200296-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200296-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200296-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200296-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200296-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200296-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200296-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200296-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200296-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200296-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200296-001	AB	1	`1e350fbaab3a…`

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	35 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
905024	Internal RxNorm lookup
905032	Internal RxNorm lookup
905041	Internal RxNorm lookup
905092	Internal RxNorm lookup
905100	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
89896dfe-f69d-4cb3-bb71-7a7c611071fa	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	SPL version
65862-519-04	Risedronate Sodium	1 in 1 CARTON	TABLET, FILM COATED	1	9
65862-519-04	Risedronate Sodium	4 in 1 BLISTER PACK	TABLET, FILM COATED	4	9
65862-519-08	Risedronate Sodium	3 in 1 CARTON	TABLET, FILM COATED	3	9
65862-519-08	Risedronate Sodium	4 in 1 BLISTER PACK	TABLET, FILM COATED	4	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-519-04	EA - Each	65862-519	c2073027-b0c0-4ef4-b6a7-4dce29837e3e	1	2016-01-13
65862-519-08	EA - Each	65862-519	cf25aa27-1b62-485c-9708-88d1ed5f6ade	1	2016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-519	RISEDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	8	Current NDC, Legacy NDC, 4 package rows	20240202_89896dfe-f69d-4cb3-bb71-7a7c611071fa.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risedronate Sodium	RISEDRONATE SODIUM	Aurobindo Pharma Limited	89896dfe-f69d-4cb3-bb71-7a7c611071fa	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200296 application number: ANDA200296 ndc (product): 65862-519

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OFG5EXG60L	RISEDRONATE SODIUM	115436-72-1	RISEDRONATE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
905100	{12 (risedronate sodium 35 MG Oral Tablet) } Pack	GPCK	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905092	{4 (risedronate sodium 35 MG Oral Tablet) } Pack	GPCK	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905032	risedronate sodium 30 MG Oral Tablet	PSN	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905100	risedronate sodium 35 MG (12) Oral Tablet Pack	PSN	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905092	risedronate sodium 35 MG (4) Oral Tablet Pack	PSN	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905024	risedronate sodium 35 MG Oral Tablet	PSN	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905041	risedronate sodium 5 MG Oral Tablet	PSN	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905032	risedronate sodium 30 MG Oral Tablet	SCD	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905024	risedronate sodium 35 MG Oral Tablet	SCD	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905041	risedronate sodium 5 MG Oral Tablet	SCD	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905100	risedronate sodium 35 MG Oral Tablet, 12 Week Pack	SY	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9
905092	risedronate sodium 35 MG Oral Tablet, 4 Week Pack	SY	89896dfe-f69d-4cb3-bb71-7a7c611071fa	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-519-26	65862051926	2500 TABLET, FILM COATED in 1 BAG (65862-519-26)	30-NOV-15	Current