Binosto

Product NDC: 70539-400
11-digit product format: 705390400
Labeler code: 70539
Product ID: 70539-400_1ff6288a-ab6b-4443-81bd-fd1a37a2bd16
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alendronate sodium
Dosage form: TABLET, EFFERVESCENT
Route: ORAL
Labeler: Radius Health, Inc.
Application: NDA202344
Marketing category: NDA
Marketing start: 2012-03-12
Substance: ALENDRONATE SODIUM
Active strength: 91.37 mg/1
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 · 9 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
2025-02-02 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	70539-400-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70539-400-94	`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	70539-400-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70539-400-94	`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	70539-400-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70539-400-94	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N202344-001	BINOSTO	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL		RLD	2012-03-12

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202344-001	9592195	2031-12-05		Drug product	2021-05-12

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202344-001	BINOSTO	EQ 70MG BASE	TABLET, EFFERVESCENT / ORAL	RLD, RS	2012-03-12	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N202344-001	9592195	2031-12-05	Drug product	2021-05-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202344-001	7488496	2023-08-11	Drug substance, Drug product	2012-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202344-001	7964212	2023-03-06	Drug substance, Drug product	2012-07-13	`3f01610625f2…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALENDRONATE SODIUM	91.37 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2UY4M2U3RA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1248077	Internal RxNorm lookup
1248083	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
09765234-01bc-40f7-b9bb-c167056f3909	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b55122e7-1795-3be6-8216-d42256d80e7d	Product name	2	20250224
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0a	Product name	1	20240513
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
70539-400-04	2025-02-24	These highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
70539-400-94	2025-02-24	These highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
70539-400-04	2025-01-30	These highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
70539-400-94	2025-01-30	These highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70539-400-00	Binosto	1 in 1 BLISTER PACK	TABLET, EFFERVESCENT	1	6
70539-400-04	Binosto	4 in 1 BOX	TABLET, EFFERVESCENT	4	6
70539-400-94	Binosto	4 in 1 BOX	TABLET, EFFERVESCENT	4	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70539-400-00	EA - Each	70539-400	34311e07-7589-4e70-8c5a-79051e6fecd4	1	2023-12-05
70539-400-04	EA - Each	70539-400	df056e85-2af3-45ec-802b-99ef3cc1b8ca	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70539-400	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [RADIUS HEALTH, INC.]	3	Current NDC, 3 package rows	20250226_09765234-01bc-40f7-b9bb-c167056f3909.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
Binosto	ALENDRONATE SODIUM	Radius Health, Inc.	09765234-01bc-40f7-b9bb-c167056f3909	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202344 application number: NDA202344 ndc (product): 70539-400

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2UY4M2U3RA	ALENDRONATE SODIUM	121268-17-5	ALENDRONATE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1248077	alendronate sodium 70 MG Effervescent Oral Tablet	PSN	09765234-01bc-40f7-b9bb-c167056f3909	6
1248083	Binosto 70 MG Effervescent Oral Tablet	PSN	09765234-01bc-40f7-b9bb-c167056f3909	6
1248083	alendronic acid 70 MG Effervescent Oral Tablet [Binosto]	SBD	09765234-01bc-40f7-b9bb-c167056f3909	6
1248077	alendronic acid 70 MG Effervescent Oral Tablet	SCD	09765234-01bc-40f7-b9bb-c167056f3909	6
1248077	alendronic acid (as alendronate sodium) 70 MG Effervescent Oral Tablet	SY	09765234-01bc-40f7-b9bb-c167056f3909	6
1248083	Binoso (alendronic acid 70 MG (as alendronate sodium)) Effervescent Oral Tablet	SY	09765234-01bc-40f7-b9bb-c167056f3909	6
1248083	Binosto 70 MG Effervescent Oral Tablet	SY	09765234-01bc-40f7-b9bb-c167056f3909	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70539-400-00	70539040000	1 in 1 BLISTER PACK					Historical
70539-400-04	70539040004	4 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)	4 blister pack	2012-03-12	No	No	Current
70539-400-94	70539040094	4 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00)	4 blister pack	2023-03-12	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Binosto	Radius Health, Inc. \| Polpharma S.A. \| SwissCo Services AG	2026-02-06	HUMAN PRESCRIPTION DRUG LABEL	6