RISEDRONATE SODIUM DELAYED-RELEASE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-09-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-01 21:25:33

Label at a glance#

ProductRisedronate Sodium

Active ingredientRISEDRONATE SODIUM ANHYDROUS

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1436-4 in blister-carton of 4 (1 x 4) Unit-dose Tablets

Risedronate Sodium Delayed-release Tablets, 35 mg

R_xonly

4 Tablets

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Risedronate Sodium
RISEDRONATE SODIUM ANHYDROUS
RISEDRONIC ACID
EDETATE DISODIUM
FERRIC OXIDE YELLOW
MAGNESIUM STEARATE
POLYSORBATE 80
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
TALC
TRIETHYL CITRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1436	70771-1436-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
RISEDRONATE SODIUM ANHYDROUS	OFG5EXG60L	ACTIB
EDETATE DISODIUM	7FLD91C86K	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER	NX76LV5T8J	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TALC	7SEV7J4R1U	IACT
TRIETHYL CITRATE	8Z96QXD6UM	IACT

Source Document#

Source XML · Source PDF

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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203822-001	RISEDRONATE SODIUM	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL			2018-09-11

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203822-001	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	2018-09-11	`f41ea6bd6efb…`

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
61f308f8-a1e8-4061-96b3-b6f92a9a588e			37c8bed0-8cfe-445d-b506-bd89c8fae1a9	2024-12-04		Exact identifier spl set id: 37c8bed0-8cfe-445d-b506-bd89c8fae1a9

Reported adverse events (FAERS/openFDA)#

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