Ibandronate Sodium

Product NDC: 65862-237
Requested package NDC: 65862-237-26
11-digit product format: 658620237
Labeler code: 65862
Product ID: 65862-237_ac6119dd-ca9a-4a6e-9a3b-4ddb60924abe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ibandronate Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA204502
Marketing category: ANDA
Marketing start: 2016-03-11
Substance: IBANDRONATE SODIUM
Active strength: 150 mg/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-237	65862-237-26	UNFINISHED	Active or certified unfinished drug listing		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 · 21 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A204502-001	IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB		2016-03-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204502-001	AB

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	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204502-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2016-03-11	`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	A204502-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204502-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204502-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204502-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204502-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204502-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204502-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204502-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204502-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204502-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204502-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204502-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204502-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204502-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204502-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204502-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204502-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204502-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204502-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204502-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204502-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204502-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204502-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204502-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204502-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204502-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204502-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204502-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204502-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204502-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204502-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204502-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204502-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204502-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204502-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204502-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204502-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204502-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204502-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204502-001	AB	1	`e64feba35796…`

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	150 mg/1

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
904932	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
86c0b4ae-5e38-4efe-88af-50ac560e294f	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
65862-237-03	Ibandronate Sodium	3 in 1 BLISTER PACK	TABLET, FILM COATED	3		12
65862-237-03	Ibandronate Sodium	1 in 1 CARTON	TABLET, FILM COATED	1		12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-237-03	EA - Each	65862-237	7c831447-4498-428d-ae68-33eeadafdcae	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-237	IBANDRONATE SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	9	Current NDC, Legacy NDC, 2 package rows	20240511_86c0b4ae-5e38-4efe-88af-50ac560e294f.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	Aurobindo Pharma Limited	86c0b4ae-5e38-4efe-88af-50ac560e294f	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204502 application number: ANDA204502 ndc (product): 65862-237

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
904932	ibandronate sodium 150 MG Oral Tablet	PSN	86c0b4ae-5e38-4efe-88af-50ac560e294f	12
904932	ibandronic acid 150 MG Oral Tablet	SCD	86c0b4ae-5e38-4efe-88af-50ac560e294f	12
904932	ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral Tablet	SY	86c0b4ae-5e38-4efe-88af-50ac560e294f	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-237-26	65862023726	2500 TABLET, FILM COATED in 1 BAG (65862-237-26)	11-MAR-16	Current