Alendronate

Product NDC: 10135-697
11-digit product format: 101350697
Labeler code: 10135
Product ID: 10135-697_76e6ead3-9532-4206-ad5f-a4a8a1eba934
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Marlex Pharmaceuticals Inc
Application: ANDA090258
Marketing category: ANDA
Marketing start: 2020-03-01
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: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	10135-697		I	Inactivated by FDA	2026-08-10
excluded package	package	10135-697	10135-697-12	I	Inactivated by FDA	2026-08-10
excluded package	package	10135-697	10135-697-20	I	Inactivated by FDA	2026-08-10
excluded package	package	10135-697	10135-697-44	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 2 · 72 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	10135-697-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-697-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	10135-697-20	`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	10135-697-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-697-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	10135-697-20	`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	10135-697-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-697-44	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	10135-697-20	`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	10135-697-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-697-44	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	10135-697-20	`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	10135-697-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-697-44	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	10135-697-20	`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	10135-697-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-697-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	10135-697-20	`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	10135-697-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-697-44	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	10135-697-20	`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	10135-697-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-697-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	10135-697-20	`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	10135-697-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-697-44	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	10135-697-20	`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	10135-697-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-697-44	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10135-697-20	`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	10135-697-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-697-44	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10135-697-20	`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	10135-697-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-697-44	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10135-697-20	`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	10135-697-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-697-44	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10135-697-20	`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	10135-697-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-697-44	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10135-697-20	`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	10135-697-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-697-44	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10135-697-20	`1332a3947898…`	`d4bfe170f9cd…`

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 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
10135-697-12	2022-01-28	C162847	48780-1	d6a99b39-88ee-a426-e053-dadaa90af4c2	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
10135-697-20	2022-01-28	C162847	48780-1	d6a99b39-88ee-a426-e053-dadaa90af4c2	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
10135-697-44	2022-01-28	C162847	48780-1	d6a99b39-88ee-a426-e053-dadaa90af4c2	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
10135-697-12	Alendronate	3 in 1 CARTON	TABLET	3	1
10135-697-12	Alendronate	4 in 1 BLISTER PACK	TABLET	4	1
10135-697-20	Alendronate	10 in 1 BLISTER PACK	TABLET	10	1
10135-697-20	Alendronate	2 in 1 CARTON	TABLET	2	1
10135-697-44	Alendronate	4 in 1 BLISTER PACK	TABLET	4	1
10135-697-44	Alendronate	1 in 1 CARTON	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
10135-697-12	EA - Each	10135-697	50c40f4a-fc15-4f28-898d-af777b8fc7c1	1	2020-05-08
10135-697-20	EA - Each	10135-697	f89fd345-558d-4520-ba90-66b32d45e15c	1	2020-05-08
10135-697-44	EA - Each	10135-697	70f5bd3c-8372-449a-a82f-68331f902a05	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10135-697	ALENDRONATE (ALENDRONATE SODIUM) TABLET [MARLEX PHARMACEUTICALS INC]	1	Legacy NDC, 6 package rows	20200410_c1e61b54-287f-47ed-9192-e3c98ecb2e06.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904396	alendronate sodium 35 MG Oral Tablet	PSN	c1e61b54-287f-47ed-9192-e3c98ecb2e06	1
904431	alendronate sodium 70 MG Oral Tablet	PSN	c1e61b54-287f-47ed-9192-e3c98ecb2e06	1
904396	alendronic acid 35 MG Oral Tablet	SCD	c1e61b54-287f-47ed-9192-e3c98ecb2e06	1
904431	alendronic acid 70 MG Oral Tablet	SCD	c1e61b54-287f-47ed-9192-e3c98ecb2e06	1
904396	alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet	SY	c1e61b54-287f-47ed-9192-e3c98ecb2e06	1
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	c1e61b54-287f-47ed-9192-e3c98ecb2e06	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
10135-697-12	10135069712	3 BLISTER PACK in 1 CARTON (10135-697-12) > 4 TABLET in 1 BLISTER PACK	3 blister pack	2020-03-01	0000-00-00	No	No	Current
10135-697-20	10135069720	2 BLISTER PACK in 1 CARTON (10135-697-20) > 10 TABLET in 1 BLISTER PACK	2 blister pack	2020-03-01	0000-00-00	No	No	Current
10135-697-44	10135069744	1 BLISTER PACK in 1 CARTON (10135-697-44) > 4 TABLET in 1 BLISTER PACK	1 blister pack	2020-03-01	0000-00-00	No	No	Current