Boniva

Product NDC: 0004-0186
11-digit product format: 000040186
Labeler code: 0004
Product ID: 0004-0186_ea7ba1c4-117f-4670-8575-0cde1c39a61a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ibandronate sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Genentech, Inc.
Application: NDA021455
Marketing category: NDA
Marketing start: 2005-03-24
Marketing end: 2023-07-31
Substance: IBANDRONATE SODIUM
Active strength: 150 mg/1
Pharmacologic classes: Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0004-0186		D	Discontinued by firm		2026-08-17
excluded package	package	0004-0186	0004-0186-83	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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0004-0186-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0004-0186-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0004-0186-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0004-0186-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0004-0186-83	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0004-0186-83	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0004-0186-83	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0004-0186-83	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0004-0186-83	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0004-0186-83	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0004-0186-83	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0004-0186-83	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021455-001	BONIVA	IBANDRONATE SODIUM	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16
N021455-002	BONIVA	IBANDRONATE SODIUM	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24

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 3 · 84 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	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021455-002	BONIVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2005-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD	2003-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL	AB	RLD, RS	2005-03-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021455-001	BONIVA	EQ 2.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2003-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021455-002	BONIVA	EQ 150MG BASE	TABLET / ORAL		RLD	2005-03-24	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021455-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021455-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021455-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021455-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021455-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021455-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021455-002	AB	1	`ea99ee380514…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 80 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	N021455-002	7192938	2023-05-06	U-798		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	7410957	2023-05-06	U-887		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021455-002	7718634	2023-05-06	U-642		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021455-002	7192938	2023-05-06	U-798		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021455-002	7410957	2023-05-06	U-887		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021455-002	7718634	2023-05-06	U-642		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021455-002	7192938	2023-05-06	U-798		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021455-002	7410957	2023-05-06	U-887		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021455-002	7718634	2023-05-06	U-642		`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021455-001	6294196	2019-10-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	6294196	2019-10-07		Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	7192938	2023-05-06	U-798		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	7410957	2023-05-06	U-887		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021455-002	7718634	2023-05-06	U-642		`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021455-002	7192938	2023-05-06	U-798		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021455-002	7410957	2023-05-06	U-887		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021455-002	7718634	2023-05-06	U-642		`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021455-002	7192938	2023-05-06	U-798		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021455-002	7410957	2023-05-06	U-887		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021455-002	7718634	2023-05-06	U-642		`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	7192938	2023-05-06	U-798		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	7410957	2023-05-06	U-887		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021455-002	7718634	2023-05-06	U-642		`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021455-002	7192938	2023-05-06	U-798		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021455-002	7410957	2023-05-06	U-887		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021455-002	7718634	2023-05-06	U-642		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021455-002	7192938	2023-05-06	U-798		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021455-002	7410957	2023-05-06	U-887		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021455-002	7718634	2023-05-06	U-642		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021455-002	7192938	2023-05-06	U-798		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021455-002	7410957	2023-05-06	U-887		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021455-002	7718634	2023-05-06	U-642		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021455-001	6294196	2019-10-07		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	6294196	2019-10-07		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	7192938	2023-05-06	U-798		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	7410957	2023-05-06	U-887		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021455-002	7718634	2023-05-06	U-642		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021455-001	6294196	2019-10-07		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021455-002	6294196	2019-10-07		Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021455-002	7192938	2023-05-06	U-798		`b00525d2431f…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578	Product name	3	20180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2	Product name	4	20160310

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0004-0186-82	EA - Each	0004-0186	7d36a8ea-ec42-4d0d-92c9-9d3ac91a6fbe	1	2012-07-24
0004-0186-83	EA - Each	0004-0186	05c92b0e-b5e9-47c2-853a-e9cc6d6cf6dd	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ibandronate sodium	ACTIVE INGREDIENT	J12U072QL0	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
ibandronic acid	ACTIVE MOIETY	UMD7G2653W	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
crospovidone	INACTIVE INGREDIENT	68401960MK	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
polyethylene glycol 6000	INACTIVE INGREDIENT	30IQX730WE	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
povidone k25	INACTIVE INGREDIENT	K0KQV10C35	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
talc	INACTIVE INGREDIENT	7SEV7J4R1U	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [GENENTECH, INC.]	22
IBANDRONATE SODIUM	ACTIVE INGREDIENT	J12U072QL0	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
IBANDRONIC ACID	ACTIVE MOIETY	UMD7G2653W	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BONIVA (IBANDRONATE SODIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J12U072QL0	IBANDRONATE SODIUM	138926-19-9	IBANDRONATE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904934	Boniva 150 MG Oral Tablet	PSN	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1
904932	ibandronate sodium 150 MG Oral Tablet	PSN	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1
904934	ibandronic acid 150 MG Oral Tablet [Boniva]	SBD	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1
904932	ibandronic acid 150 MG Oral Tablet	SCD	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1
904934	Boniva 150 MG (as ibandronate sodium 168.75 MG) Oral Tablet	SY	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1
904934	Boniva 150 MG Oral Tablet	SY	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1
904932	ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral Tablet	SY	d6d7711f-541b-47d1-b937-2c6a021eb6c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0004-0186-83	00004018683	1 BLISTER PACK in 1 BOX (0004-0186-83) > 3 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2014-12-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Boniva	Genentech, Inc. \| Roche Diagnostics GmbH \| F. Hoffmann-La Roche Ltd \| F. Hoffmann-La Roche AG	2021-11-16	HUMAN PRESCRIPTION DRUG LABEL	30
Boniva	Physicians Total Care, Inc.	2010-12-02	HUMAN PRESCRIPTION DRUG LABEL	1