Alendronate Sodium

Product NDC: 63187-175
11-digit product format: 631870175
Labeler code: 63187
Product ID: 63187-175_bb5eba61-3503-4509-bf51-f28e40c94aa3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA075710
Marketing category: ANDA
Marketing start: 2008-02-06
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: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63187-175		D	Discontinued by firm		2026-08-10
excluded package	package	63187-175	63187-175-04	D	Discontinued by firm		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 1 · 24 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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`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	63187-175-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A075710-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06
A075710-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06
A075710-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06
A075710-004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06
A075710-005	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06

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 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075710-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-005	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075710-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075710-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075710-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075710-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075710-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075710-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-005	AB	1	`ea99ee380514…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALENDRONATE SODIUM	ACTIVE INGREDIENT	2UY4M2U3RA	ALENDRONATE SODIUM TABLET [PROFICIENT RX LP]	1
ALENDRONIC ACID	ACTIVE MOIETY	X1J18R4W8P	ALENDRONATE SODIUM TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALENDRONATE SODIUM TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALENDRONATE SODIUM TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALENDRONATE SODIUM TABLET [PROFICIENT RX LP]	1

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
Alendronate Sodium	ALENDRONATE SODIUM	Amneal Pharmaceuticals of New York LLC	c23fb7fe-c6b9-4f77-bde7-992222b589d3	2021-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075710 application number: ANDA075710