Binosto

Product NDC: 0178-0101
11-digit product format: 001780101
Labeler code: 0178
Product ID: 0178-0101_78d320a1-3ec7-1a45-e053-2a91aa0a1f9b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alendronate sodium
Dosage form: TABLET, EFFERVESCENT
Route: ORAL
Labeler: Mission Pharmacal Company
Application: NDA202344
Marketing category: NDA
Marketing start: 2012-09-03
Marketing end: 0000-00-00
Substance: ALENDRONATE SODIUM
Active strength: 70 mg/1
Pharmacologic classes: Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0178-0101		I	Inactivated by FDA	2026-08-10
excluded package	package	0178-0101	0178-0101-01	I	Inactivated by FDA	2026-08-10
excluded package	package	0178-0101	0178-0101-02	I	Inactivated by FDA	2026-08-10

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 2 · 63 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	0178-0101-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0178-0101-01	`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	0178-0101-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0178-0101-01	`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	0178-0101-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0178-0101-01	`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	0178-0101-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0178-0101-01	`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	0178-0101-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0178-0101-01	`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	0178-0101-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0178-0101-01	`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	0178-0101-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0178-0101-01	`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	0178-0101-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0178-0101-01	`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	0178-0101-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0178-0101-01	`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	0178-0101-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0178-0101-01	`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	0178-0101-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0178-0101-01	`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	0178-0101-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0178-0101-01	`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	0178-0101-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	0178-0101-01	`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	0178-0101-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	0178-0101-01	`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	0178-0101-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	0178-0101-01	`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	0178-0101-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	0178-0101-01	`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	0178-0101-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	0178-0101-01	`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	0178-0101-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	0178-0101-01	`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	0178-0101-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	0178-0101-01	`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	0178-0101-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0178-0101-01	`e2bbac7714bc…`	`27bdfed8d636…`

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…`

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0178-0101-01	2020-01-31	C162847	48780-1	9d75b9d0-1d50-f424-e053-dadaa90a57ce	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
0178-0101-02	2020-01-31	C162847	48780-1	9d75b9d0-1d50-f424-e053-dadaa90a57ce	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	Strength	SPL version
0178-0101-01	Binosto	1 in 1 CARTON	TABLET, EFFERVESCENT	1		9
0178-0101-02	Binosto	4 in 1 CARTON	TABLET, EFFERVESCENT	4		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0178-0101-02	EA - Each	0178-0101	18362c3e-7e91-4e01-bee5-1324bfefc903	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
alendronate sodium	ACTIVE INGREDIENT	2UY4M2U3RA	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
ALENDRONIC ACID	ACTIVE MOIETY	X1J18R4W8P	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
Acesulfame potassium	INACTIVE INGREDIENT	23OV73Q5G9	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
Anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
Monosodium citrate	INACTIVE INGREDIENT	68538UP9SE	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
Sodium bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
Sodium carbonate	INACTIVE INGREDIENT	45P3261C7T	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7
Sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0178-0101	BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [MISSION PHARMACAL COMPANY]	9	Legacy NDC, 2 package rows	20181023_ad670460-141b-e481-f713-7aed9485de8d.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

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	ad670460-141b-e481-f713-7aed9485de8d	9
1248083	Binosto 70 MG Effervescent Oral Tablet	PSN	ad670460-141b-e481-f713-7aed9485de8d	9
1248083	alendronic acid 70 MG Effervescent Oral Tablet [Binosto]	SBD	ad670460-141b-e481-f713-7aed9485de8d	9
1248077	alendronic acid 70 MG Effervescent Oral Tablet	SCD	ad670460-141b-e481-f713-7aed9485de8d	9
1248077	alendronic acid (as alendronate sodium) 70 MG Effervescent Oral Tablet	SY	ad670460-141b-e481-f713-7aed9485de8d	9
1248083	Binoso (alendronic acid 70 MG (as alendronate sodium)) Effervescent Oral Tablet	SY	ad670460-141b-e481-f713-7aed9485de8d	9
1248083	Binosto 70 MG Effervescent Oral Tablet	SY	ad670460-141b-e481-f713-7aed9485de8d	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
0178-0101-01	00178010101	1 in 1 CARTON	Historical
0178-0101-02	00178010102	4 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Binosto	Mission Pharmacal Company \| SwissCo Services AG	2018-10-22	HUMAN PRESCRIPTION DRUG LABEL	9