Alendronate Sodium

Product NDC: 33261-993
11-digit product format: 332610993
Labeler code: 33261
Product ID: 33261-993_78a8700b-3eb9-4c00-b274-3bddc6208a34
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA075710
Marketing category: ANDA
Marketing start: 2008-02-06
Marketing end: 0000-00-00
Substance: ALENDRONATE SODIUM
Active strength: 35 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	33261-993		I	Inactivated by FDA		2026-08-10
excluded package	package	33261-993	33261-993-01	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 1 · 42 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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`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	33261-993-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	33261-993-01	`9bebd1f3094a…`	`5416666fcb17…`

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 Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b55122e7-1795-3be6-8216-d42256d80e7d	Product name	2	20250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0a	Product name	1	20240513
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
33261-993-01	2020-01-31	C162847	48780-1	9d75b9d0-583f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Alendronate Sodium Tablets USP safely and effectively. See full prescribing information for Alendronate Sodium Tablets USP. ALENDRONATE Sodium Tablets USP for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
33261-993-01	Alendronate Sodium	4 in 1 BOX	TABLET	4		1
33261-993-01	Alendronate Sodium	1 in 1 BLISTER PACK	TABLET	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33261-993-01	EA - Each	33261-993	a2a73a30-5977-4f27-a70c-b96e011d75ec	1	2015-10-02

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33261-993	ALENDRONATE SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 2 package rows	20131203_f3840bb8-f1aa-4d20-bca1-c0b986e40f22.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
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

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
904396	alendronate sodium 35 MG Oral Tablet	PSN	f3840bb8-f1aa-4d20-bca1-c0b986e40f22	1
904396	alendronic acid 35 MG Oral Tablet	SCD	f3840bb8-f1aa-4d20-bca1-c0b986e40f22	1
904396	alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet	SY	f3840bb8-f1aa-4d20-bca1-c0b986e40f22	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33261-993-01	33261099301	4 in 1 BOX	Historical