Alendronate

Product NDC: 63629-7329
11-digit product format: 636297329
Labeler code: 63629
Product ID: 63629-7329_ce7ec70e-8f59-43f9-af6c-678760e76ef9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALENDRONATE SODIUM
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090258
Marketing category: ANDA
Marketing start: 2016-05-12
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: 2023-12-31
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	63629-7329		D	Discontinued by firm		2026-08-10
excluded package	package	63629-7329	63629-7329-1	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 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63629-7329-1	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63629-7329-1	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	63629-7329-1	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	63629-7329-1	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	63629-7329-1	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	63629-7329-1	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	63629-7329-1	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	63629-7329-1	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	63629-7329-1	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	63629-7329-1	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	63629-7329-1	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	63629-7329-1	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	63629-7329-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-7329-1	2020-10-16	C162847	48780-1	9d75b9d0-f463-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Alendronate Sodium Tablets safely and effectively. See full prescribing information for alendronate sodium tablets, USP. Alendronate Sodium Tablets USP, for oral use Initial U.S. Approval: 1995
63629-7329-1	2020-01-31	C162847	48780-1	9d75b9d0-f463-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Alendronate Sodium Tablets safely and effectively. See full prescribing information for alendronate sodium tablets, USP. Alendronate Sodium Tablets USP, for oral use Initial U.S. Approval: 1995

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
63629-7329-1	63629732901	4 TABLET in 1 BOTTLE (63629-7329-1)	4 tablet	2017-07-14	0000-00-00	No	No	Current