IBANDRONATE SODIUM

Product NDC: 60505-2795
11-digit product format: 605052795
Labeler code: 60505
Product ID: 60505-2795_31cdb988-ed22-4f0d-d1c2-8e89aae8c703
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: IBANDRONATE SODIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp
Application: ANDA078948
Marketing category: ANDA
Marketing start: 2012-03-19
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-2795		I	Inactivated by FDA		2026-08-17
excluded package	package	60505-2795	60505-2795-0	I	Inactivated by FDA		2026-08-17

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
A078948-001	IBANDRONATE SODIUM	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB		2012-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078948-001	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	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078948-001	IBANDRONATE SODIUM	EQ 150MG BASE	TABLET / ORAL	AB	2012-03-19	`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	A078948-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078948-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078948-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078948-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078948-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078948-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078948-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078948-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078948-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078948-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078948-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078948-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078948-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078948-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078948-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078948-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078948-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078948-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078948-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078948-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078948-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078948-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078948-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078948-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078948-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078948-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078948-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078948-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078948-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078948-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078948-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078948-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078948-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078948-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078948-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078948-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078948-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078948-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078948-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A078948-001	AB	1	`e64feba35796…`

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
60505-2795-0	IBANDRONATE SODIUM	1 in 1 BLISTER PACK	TABLET, FILM COATED	1		20
60505-2795-0	IBANDRONATE SODIUM	3 in 1 PACKAGE	TABLET, FILM COATED	3		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-2795-0	EA - Each	60505-2795	50331f9d-4515-4164-8df1-df5bb19aac71	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
IBANDRONATE SODIUM	ACTIVE INGREDIENT	J12U072QL0	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
IBANDRONIC ACID	ACTIVE MOIETY	UMD7G2653W	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60505-2795	IBANDRONATE SODIUM TABLET, FILM COATED [APOTEX CORP]	17	Current NDC, Legacy NDC, 2 package rows	20250413_dd674424-b151-d7eb-3acf-b1589347f2f7.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	Golden State Medical Supply, Inc.	618e1aff-ccbb-4cee-93f1-fe04e33dacb7	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078948 application number: ANDA078948

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	dd674424-b151-d7eb-3acf-b1589347f2f7	20
904932	ibandronic acid 150 MG Oral Tablet	SCD	dd674424-b151-d7eb-3acf-b1589347f2f7	20
904932	ibandronic acid 150 MG (as ibandronate sodium 168.75 MG) Oral Tablet	SY	dd674424-b151-d7eb-3acf-b1589347f2f7	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-2795-0	60505279500	3 BLISTER PACK in 1 PACKAGE (60505-2795-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK	3 blister pack	2012-03-19	0000-00-00	No	No	Current