ALENDRONATE SODIUM

Product NDC: 68071-3171
Requested package NDC: 68071-3171-4
11-digit product format: 680713171
Labeler code: 68071
Product ID: 68071-3171_bb13d5e3-49a5-b2c4-e053-2995a90a00d6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate sodium
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA076768
Marketing category: ANDA
Marketing start: 2008-08-04
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-3171	68071-3171-4	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 · 15 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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	TE codes	Approval date
A076768-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-005	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A076768-001	AB
A076768-002	AB
A076768-003	AB
A076768-004	AB
A076768-005	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 6 · 205 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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-005	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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-002	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	A076768-003	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	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-005	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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-002	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	A076768-003	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	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-005	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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-002	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	A076768-003	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	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-005	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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-002	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	A076768-003	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	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-005	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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-002	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	A076768-003	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	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-005	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	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-002	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	A076768-003	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	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A076768-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076768-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-005	AB	1	`5bbf6a4d5a75…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-07-19	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. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995
2023-01-30	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. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995
2021-02-11	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. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval:1995
2021-01-29	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. ALENDRONATE SODIUM tablets, 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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c7e470d6-508e-466e-a78d-060bbbc9745c	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	54d6543d-4239-58b1-e054-00144ff88e88	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c4358ba7-1bf8-4b0a-9407-5ac279d04555	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Cipla USA Inc.	e2fac28d-ad91-4cdc-a003-9fdeac073f76	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Preferred Pharmaceuticals Inc.	83e3ba94-d882-4b5c-87cb-af1eb0997efc	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	A-S Medication Solutions	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals, Inc.	2baf8516-4148-9007-e063-6394a90a8094	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EXELAN PHARMACEUTICALS INC.	91a0f73a-d8cd-4197-b431-40707a2150b9	2023-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768

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
68071-3171-4	68071317104	4 TABLET in 1 BOX (68071-3171-4)	4 tablet	2017-03-16	0000-00-00	No	No	Current