Alendronate Sodium

Product NDC: 68788-8235
11-digit product format: 687888235
Labeler code: 68788
Product ID: 68788-8235_172d65f1-1dc8-45df-8575-0efedcf021a4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA090124
Marketing category: ANDA
Marketing start: 2022-08-09
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: 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	68788-8235		D	Discontinued by firm		2026-08-10
excluded package	package	68788-8235	68788-8235-4	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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`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	68788-8235-4	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090124-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04
A090124-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04
A090124-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090124-001	AB
A090124-002	AB
A090124-003	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 4 · 123 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	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090124-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090124-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090124-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090124-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8235-4	EA - Each	68788-8235	b3c7d952-98f5-4a8f-be53-3393dbd73eee	1	2022-09-12

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alendronate Sodium	ALENDRONATE SODIUM	Rising Pharma Holdings, Inc.	ffdd2496-d253-419b-85a6-8c615f7545f1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	NorthStar Rx LLC	4323d3aa-cbb0-41e2-aba7-7a94a0516993	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	d52cf007-5775-4dea-9f43-b1907b6ffe81	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	Aurobindo Pharma Limited	815a87c4-e489-4eb9-9a2e-fb7a16642f01	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	eeb65442-6b3c-485c-9c5d-9cf40df4451e	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	873442b0-1932-4fa6-ba25-b4d3505f4128	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	Proficient Rx LP	6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124

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
68788-8235-4	68788823504	1 BLISTER PACK in 1 CARTON (68788-8235-4) > 4 TABLET in 1 BLISTER PACK	1 blister pack	2022-08-09	0000-00-00	No	No	Current