Atelvia

Product NDC: 0430-0979
11-digit product format: 004300979
Labeler code: 0430
Product ID: 0430-0979_936662af-4e07-4361-b7ef-760ebfad3e01
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: risedronate sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA022560
Marketing category: NDA
Marketing start: 2010-12-01
Substance: RISEDRONATE SODIUM HEMIPENTAHYDRATE; RISEDRONATE SODIUM MONOHYDRATE
Active strength: 30.1; 4.9 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N022560-001	ATELVIA	RISEDRONATE SODIUM	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022560-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022560-001	8246989	2026-01-16		Drug product	2012-08-28
N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01
N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01

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 · 42 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	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022560-001	ATELVIA	35MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2010-10-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N022560-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022560-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022560-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022560-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022560-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022560-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022560-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022560-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022560-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022560-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022560-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022560-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022560-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022560-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022560-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022560-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022560-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022560-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022560-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022560-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022560-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022560-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022560-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022560-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022560-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022560-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022560-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022560-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022560-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022560-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022560-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022560-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022560-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022560-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022560-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022560-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022560-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022560-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022560-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022560-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022560-001	7645459	2028-01-09	U-662	Drug product	2010-11-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022560-001	7645460	2028-01-09	U-662	Drug product	2010-11-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022560-001	8246989	2026-01-16		Drug product	2012-08-28	`1e350fbaab3a…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RISEDRONATE SODIUM HEMIPENTAHYDRATE	30.1 mg/1
RISEDRONATE SODIUM MONOHYDRATE	4.9 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1020064	Internal RxNorm lookup
1020065	Internal RxNorm lookup
1020066	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
c8b9ab88-1a26-46c3-80ec-4eaa45202021	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
0430-0979-03	Atelvia	4 in 1 DOSE PACK	TABLET, DELAYED RELEASE	4		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0430-0979-03	EA - Each	0430-0979	4f8e2f3d-ce56-4485-b7ee-30a28901e642	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	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
RISEDRONATE SODIUM MONOHYDRATE	ACTIVE INGREDIENT	F67L43UT5C	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
RISEDRONIC ACID	ACTIVE MOIETY	KM2Z91756Z	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [WARNER CHILCOTT (US), LLC]	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0430-0979	ATELVIA (RISEDRONATE SODIUM) TABLET, DELAYED RELEASE [ALLERGAN, INC.]	24	Current NDC, Legacy NDC, 1 package rows	20240913_c8b9ab88-1a26-46c3-80ec-4eaa45202021.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
Atelvia	RISEDRONATE SODIUM	Allergan, Inc.	c8b9ab88-1a26-46c3-80ec-4eaa45202021	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022560 application number: NDA022560 ndc (product): 0430-0979
Risedronate Sodium	RISEDRONATE SODIUM	Mylan Pharmaceuticals, Inc.	c89430be-15f1-4b8b-ab7e-738de716ee7d	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022560 application number: NDA022560

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
1020066	{4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } Pack [Atelvia]	BPCK	c8b9ab88-1a26-46c3-80ec-4eaa45202021	29
1020065	{4 (risedronate sodium 35 MG Delayed Release Oral Tablet) } Pack	GPCK	c8b9ab88-1a26-46c3-80ec-4eaa45202021	29
1020066	Atelvia 35 MG Delayed Release Oral Tablet Once-a-Week Pack	PSN	c8b9ab88-1a26-46c3-80ec-4eaa45202021	29
1020064	risedronate sodium 35 MG Delayed Release Oral Tablet	PSN	c8b9ab88-1a26-46c3-80ec-4eaa45202021	29
1020065	risedronate sodium 35 MG Delayed Release Oral Tablet 4 Count Pack	PSN	c8b9ab88-1a26-46c3-80ec-4eaa45202021	29
1020064	risedronate sodium 35 MG Delayed Release Oral Tablet	SCD	c8b9ab88-1a26-46c3-80ec-4eaa45202021	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0430-0979-03	00430097903	4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)	2010-12-01	0000-00-00	No	No	Current