IBANDRONATE SODIUM

Product NDC: 62756-218
11-digit product format: 627560218
Labeler code: 62756
Product ID: 62756-218_61378ee8-cc2f-4f55-954b-4eb55e975f5c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IBANDRONATE SODIUM
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA090853
Marketing category: ANDA
Marketing start: 2014-02-15
Substance: IBANDRONATE SODIUM
Active strength: 3 mg/3mL
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 42 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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`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	62756-218-40	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	62756-218-40	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	62756-218-40	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	62756-218-40	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	62756-218-40	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	62756-218-40	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	62756-218-40	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	62756-218-40	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	62756-218-40	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	62756-218-40	`9bebd1f3094a…`	`5416666fcb17…`

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
A090853-001	IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS			2014-02-14

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS		2014-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090853-001	IBANDRONATE SODIUM	EQ 3MG BASE/3ML	INJECTABLE / INTRAVENOUS	AP	2014-02-14	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A090853-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090853-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090853-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090853-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090853-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090853-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090853-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090853-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090853-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090853-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090853-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090853-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090853-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090853-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090853-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090853-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090853-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090853-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090853-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090853-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090853-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090853-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090853-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090853-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090853-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090853-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090853-001	AP	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
IBANDRONATE SODIUM	3 mg/3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J12U072QL0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904955	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
be514be6-727a-4d6c-993b-52144f8e6de8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
fca0fe5b-9e2b-f6fc-e68d-b5f751d08578	Product name	3	20180103
a7e2afc7-9184-42ab-b6c6-6edca00dd2d2	Product name	4	20160310
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
62756-218-40	2020-01-31	C162847	48780-1	9d75b9d0-64a2-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use IBANDRONATE SODIUM INJECTION safely and effectively. See full prescribing information for IBANDRONATE SODIUM INJECTION. IBANDRONATE SODIUM injection, for intravenous use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62756-218-40	IBANDRONATE SODIUM	1 in 1 CARTON	INJECTION, SOLUTION	1		6
62756-218-40	IBANDRONATE SODIUM	3 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	3		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62756-218-40	ML - Milliliter	62756-218	565fb9b7-bd67-4701-add4-fc4a163300bd	1	2014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBANDRONATE SODIUM	ACTIVE INGREDIENT	J12U072QL0	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
IBANDRONIC ACID	ACTIVE MOIETY	UMD7G2653W	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
ACETIC ACID	INACTIVE INGREDIENT	Q40Q9N063P	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
SODIUM ACETATE	INACTIVE INGREDIENT	4550K0SC9B	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62756-218	IBANDRONATE SODIUM INJECTION, SOLUTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]	5	Current NDC, Legacy NDC, 2 package rows	20181026_be514be6-727a-4d6c-993b-52144f8e6de8.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
IBANDRONATE SODIUM	IBANDRONATE SODIUM	Sun Pharmaceutical Industries, Inc.	be514be6-727a-4d6c-993b-52144f8e6de8	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090853 application number: ANDA090853 ndc (product): 62756-218

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
904955	ibandronate sodium 3 MG in 3 ML Injection	PSN	be514be6-727a-4d6c-993b-52144f8e6de8	6
904955	3 ML ibandronic acid 1 MG/ML Injection	SCD	be514be6-727a-4d6c-993b-52144f8e6de8	6
904955	ibandronic acid 1 MG/ML (as ibandronate sodium 1.13 MG/ML) Injection	SY	be514be6-727a-4d6c-993b-52144f8e6de8	6
904955	ibandronic acid 3 MG per 3 ML (as ibandronate sodium 1.13 MG/ML) Injection	SY	be514be6-727a-4d6c-993b-52144f8e6de8	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
62756-218-40	62756021840	1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) / 3 mL in 1 VIAL, SINGLE-DOSE	2014-02-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IBANDRONATE SODIUM	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2026-03-03	Human Prescription Drug Label	6