RISEDRONATE SODIUM

Product NDC: 63304-440
11-digit product format: 633040440
Labeler code: 63304
Product ID: 63304-440_d97c9e6a-01e9-46ae-9088-0ca86b4eb842
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: RISEDRONATE SODIUM
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Sun Pharmaceutical Industires Inc.
Application: ANDA203925
Marketing category: ANDA
Marketing start: 2019-07-10
Marketing end: 0000-00-00
Substance: RISEDRONATE SODIUM
Active strength: 35 mg/1
Pharmacologic classes: Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63304-440		D	Discontinued by firm		2026-10-28
excluded package	package	63304-440	63304-440-09	D	Discontinued by firm		2026-10-28

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203925-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL			2019-07-09

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 2 · 44 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
2026-10-15 13:18:30	2026-09	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL		2019-07-09	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL		2019-07-09	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL		2019-07-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL		2019-07-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL		2019-07-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL		2019-07-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203925-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	2019-07-09	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203925-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203925-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203925-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203925-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203925-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203925-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203925-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203925-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203925-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203925-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203925-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203925-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203925-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203925-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203925-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203925-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203925-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203925-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203925-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203925-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203925-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203925-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203925-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203925-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203925-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203925-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203925-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203925-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203925-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203925-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203925-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203925-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203925-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203925-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203925-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203925-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203925-001	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
63304-440-09	RISEDRONATE SODIUM	1 in 1 CARTON	TABLET, DELAYED RELEASE	1		4
63304-440-11	RISEDRONATE SODIUM	4 in 1 DOSE PACK	TABLET, DELAYED RELEASE	4		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-440-09	EA - Each	63304-440	2120524a-bab1-41a0-9102-ed0f5bbe09c1	1	2019-09-05
63304-440-11	EA - Each	63304-440	24b22388-187b-486f-a434-6bbe32897ade	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-440	RISEDRONATE SODIUM TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTIRES INC.]	4	Legacy NDC, 2 package rows	20200910_1d9e520b-2fa6-4603-b397-f0fc24fae775.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	Sun Pharmaceutical Industires Inc.	1d9e520b-2fa6-4603-b397-f0fc24fae775	2020-09-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203925 application number: ANDA203925 ndc (product): 63304-440

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
1020065	{4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } Pack	GPCK	1d9e520b-2fa6-4603-b397-f0fc24fae775	4
1020064	risedronate sodium 35 MG Delayed Release Oral Tablet	PSN	1d9e520b-2fa6-4603-b397-f0fc24fae775	4
1020065	risedronate sodium 35 MG Delayed Release Oral Tablet 4 Count Pack	PSN	1d9e520b-2fa6-4603-b397-f0fc24fae775	4
1020064	risedronate sodium 35 MG Delayed Release Oral Tablet	SCD	1d9e520b-2fa6-4603-b397-f0fc24fae775	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-440-09	63304044009	1 DOSE PACK in 1 CARTON (63304-440-09) > 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (63304-440-11)	1 dose pack	2019-07-10	0000-00-00	No	No	Current
63304-440-11	63304044011	4 in 1 DOSE PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
RISEDRONATE SODIUM	Sun Pharmaceutical Industires Inc. \| Sun Pharmaceutical Industires Limited	2020-09-09	HUMAN PRESCRIPTION DRUG LABEL	4