Alendronate

Product NDC: 69543-131
11-digit product format: 695430131
Labeler code: 69543
Product ID: 69543-131_91a3617f-bde7-4868-9334-f6f61e8440d1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALENDRONATE SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Virtus Pharmaceuticals
Application: ANDA090258
Marketing category: ANDA
Marketing start: 2015-10-02
Marketing end: 2024-03-30
Substance: ALENDRONATE SODIUM
Active strength: 70 mg/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69543-131		D	Discontinued by firm	2026-08-10
excluded package	package	69543-131	69543-131-04	D	Discontinued by firm	2026-08-10
excluded package	package	69543-131	69543-131-12	D	Discontinued by firm	2026-08-10
excluded package	package	69543-131	69543-131-20	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 · 48 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	69543-131-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69543-131-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69543-131-04	`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	69543-131-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69543-131-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69543-131-04	`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	69543-131-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69543-131-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69543-131-04	`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	69543-131-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69543-131-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69543-131-04	`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	69543-131-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69543-131-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69543-131-04	`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	69543-131-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69543-131-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69543-131-04	`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	69543-131-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69543-131-20	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69543-131-04	`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	69543-131-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69543-131-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69543-131-04	`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	69543-131-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69543-131-20	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69543-131-04	`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	69543-131-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69543-131-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69543-131-04	`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	69543-131-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69543-131-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69543-131-04	`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	69543-131-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69543-131-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69543-131-04	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090258-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24
A090258-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24
A090258-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24
A090258-004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A090258-001	AB
A090258-002	AB
A090258-003	AB
A090258-004	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 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090258-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-004	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2009-09-24	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090258-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090258-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090258-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090258-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090258-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090258-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090258-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090258-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090258-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090258-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090258-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090258-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090258-004	AB	1	`d06236e962d9…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-131-04	EA - Each	69543-131	c5a52141-7dcf-4597-8e72-69dbaeff8f28	1	2015-11-12
69543-131-12	EA - Each	69543-131	6896bdd3-be95-42c3-a913-067bab510f76	1	2015-11-12
69543-131-20	EA - Each	69543-131	693be3ab-ab73-41c4-a2be-93683e4861d7	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALENDRONATE SODIUM	ACTIVE INGREDIENT	2UY4M2U3RA	ALENDRONATE (ALENDRONATE SODIUM) TABLET [VIRTUS PHARMACEUTICALS]	1
ALENDRONIC ACID	ACTIVE MOIETY	X1J18R4W8P	ALENDRONATE (ALENDRONATE SODIUM) TABLET [VIRTUS PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ALENDRONATE (ALENDRONATE SODIUM) TABLET [VIRTUS PHARMACEUTICALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	ALENDRONATE (ALENDRONATE SODIUM) TABLET [VIRTUS PHARMACEUTICALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ALENDRONATE (ALENDRONATE SODIUM) TABLET [VIRTUS PHARMACEUTICALS]	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alendronate	ALENDRONATE SODIUM	Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.	a24fd39c-34a7-4de2-9439-781e612189ca	2025-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090258 application number: ANDA090258
Alendronate	ALENDRONATE SODIUM TABLET	Marlex Pharmaceuticals, Inc.	b63421af-ec03-1de7-e053-2a95a90abec6	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090258 application number: ANDA090258

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69543-131-04	69543013104	1 BLISTER PACK in 1 CARTON (69543-131-04) > 4 TABLET in 1 BLISTER PACK	1 blister pack	2015-10-02	2024-03-30	No	No	Current
69543-131-12	69543013112	3 BLISTER PACK in 1 CARTON (69543-131-12) > 4 TABLET in 1 BLISTER PACK	3 blister pack	2016-02-23	0000-00-00	No	No	Current
69543-131-20	69543013120	2 BLISTER PACK in 1 CARTON (69543-131-20) > 10 TABLET in 1 BLISTER PACK	2 blister pack	2016-02-23	2023-03-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alendronate	Virtus Pharmaceuticals	2022-08-16	HUMAN PRESCRIPTION DRUG LABEL	9
Alendronate	A-S Medication Solutions	2018-02-16	HUMAN PRESCRIPTION DRUG LABEL	4
Alendronate	NuCare Pharmaceuticals,Inc.	2017-08-31	HUMAN PRESCRIPTION DRUG LABEL	1