FOSAMAX

Product NDC: 0006-0031
11-digit product format: 000060031
Labeler code: 0006
Product ID: 0006-0031_37333f48-be6f-455d-878b-328bc51259c4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alendronate sodium
Dosage form: TABLET
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA020560
Marketing category: NDA
Marketing start: 1995-09-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0006-0031		D	Discontinued by firm		2026-08-10
excluded package	package	0006-0031	0006-0031-44	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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`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	0006-0031-44	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	RLD / RS	Approval date
N020560-001	FOSAMAX	ALENDRONATE SODIUM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29
N020560-002	FOSAMAX	ALENDRONATE SODIUM	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29
N020560-003	FOSAMAX	ALENDRONATE SODIUM	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25
N020560-004	FOSAMAX	ALENDRONATE SODIUM	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20
N020560-005	FOSAMAX	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020560-005	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-001	FOSAMAX	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-002	FOSAMAX	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-003	FOSAMAX	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-004	FOSAMAX	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N020560-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020560-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020560-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020560-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020560-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020560-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020560-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020560-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020560-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020560-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020560-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020560-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020560-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020560-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020560-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020560-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020560-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020560-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020560-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020560-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020560-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020560-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020560-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020560-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020560-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020560-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020560-005	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020560-005	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020560-005	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020560-005	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020560-005	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020560-005	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020560-005	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020560-005	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020560-005	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020560-005	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020560-005	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020560-005	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020560-005	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020560-005	AB	1	`cb3db0bc1861…`

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0031-21	EA - Each	0006-0031	7ae02577-30e3-412f-9420-557385a8ab48	1	2015-10-02
0006-0031-44	EA - Each	0006-0031	f9cc1e18-c522-418b-8a47-d86c440da4af	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALENDRONATE SODIUM	ACTIVE INGREDIENT	2UY4M2U3RA	FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.]	32
ALENDRONIC ACID	ACTIVE MOIETY	X1J18R4W8P	FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.]	32
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.]	32
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.]	32
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.]	32
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FOSAMAX (ALENDRONATE SODIUM) TABLET [MERCK SHARP & DOHME CORP.]	32
ALENDRONATE SODIUM	ACTIVE INGREDIENT	2UY4M2U3RA	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
ALENDRONIC ACID	ACTIVE MOIETY	X1J18R4W8P	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FOSAMAX (ALENDRONATE SODIUM) TABLET FOSAMAX (ALENDRONATE SODIUM) TABLET, COATED [PHYSICIANS TOTAL CARE, INC.]	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOSAMAX	ALENDRONATE SODIUM	Organon LLC	14e931fd-2c5f-4d90-b7db-5980706f4a56	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020560 application number: NDA020560

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
904419	alendronate sodium 10 MG Oral Tablet	PSN	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904396	alendronate sodium 35 MG Oral Tablet	PSN	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904425	alendronate sodium 5 MG Oral Tablet	PSN	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904431	alendronate sodium 70 MG Oral Tablet	PSN	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904399	FOSAMAX 35 MG Oral Tablet	PSN	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904433	FOSAMAX 70 MG Oral Tablet	PSN	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904421	alendronic acid 10 MG Oral Tablet [Fosamax]	SBD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904399	alendronic acid 35 MG Oral Tablet [Fosamax]	SBD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904427	alendronic acid 5 MG Oral Tablet [Fosamax]	SBD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904433	alendronic acid 70 MG Oral Tablet [Fosamax]	SBD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904419	alendronic acid 10 MG Oral Tablet	SCD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904396	alendronic acid 35 MG Oral Tablet	SCD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904425	alendronic acid 5 MG Oral Tablet	SCD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904431	alendronic acid 70 MG Oral Tablet	SCD	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904419	alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904396	alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904425	alendronic acid 5 MG (as alendronate sodium 6.53 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904421	Fosamax 10 MG (as alendronate sodium 13.1 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904421	Fosamax 10 MG Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904399	Fosamax 35 MG (as alendronate sodium 45.7 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904399	Fosamax 35 MG Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904427	Fosamax 5 MG (as alendronate sodium 6.53 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904427	Fosamax 5 MG Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904433	Fosamax 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1
904433	Fosamax 70 MG Oral Tablet	SY	e6ffadda-2ace-4e99-8bb4-75631c54f39b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-0031-44	00006003144	4 TABLET in 1 BLISTER PACK (0006-0031-44)	4 tablet	1995-09-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FOSAMAX	Merck Sharp & Dohme Corp.	2020-11-18	HUMAN PRESCRIPTION DRUG LABEL	37
Fosamax - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-03-05	HUMAN PRESCRIPTION DRUG LABEL	1