FOSAMAX PLUS D

Product NDC: 0006-0270
11-digit product format: 000060270
Labeler code: 0006
Product ID: 0006-0270_31045bcd-e069-4541-8cfb-58442e7c3435
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALENDRONATE SODIUM and CHOLECALCIFEROL
Dosage form: TABLET
Route: ORAL
Labeler: Merck Sharp & Dohme Corp.
Application: NDA021762
Marketing category: NDA
Marketing start: 2005-04-07
Marketing end: 0000-00-00
Substance: ALENDRONATE SODIUM; CHOLECALCIFEROL
Active strength: 70 mg/1; [iU]/1
Pharmacologic classes: Bisphosphonate [EPC],Diphosphonates [CS],Vitamin D [CS],Vitamin D [EPC]
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0006-0270		D	Discontinued by firm	2026-08-17
excluded package	package	0006-0270	0006-0270-21	D	Discontinued by firm	2026-08-17
excluded package	package	0006-0270	0006-0270-44	D	Discontinued by firm	2026-08-17

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 · 36 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	0006-0270-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0006-0270-44	`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	0006-0270-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0006-0270-44	`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	0006-0270-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0006-0270-44	`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	0006-0270-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0006-0270-44	`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	0006-0270-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0006-0270-44	`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	0006-0270-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0006-0270-44	`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	0006-0270-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0006-0270-44	`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	0006-0270-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0006-0270-44	`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	0006-0270-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0006-0270-44	`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	0006-0270-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0006-0270-44	`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	0006-0270-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0006-0270-44	`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	0006-0270-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0006-0270-44	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021762-001	FOSAMAX PLUS D	ALENDRONATE SODIUM; CHOLECALCIFEROL	EQ 70MG BASE;2,800 IU	TABLET / ORAL		RLD	2005-04-07
N021762-002	FOSAMAX PLUS D	ALENDRONATE SODIUM; CHOLECALCIFEROL	EQ 70MG BASE;5,600 IU	TABLET / ORAL		RLD, RS	2007-04-26

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021762-001	FOSAMAX PLUS D	EQ 70MG BASE;2,800 IU	TABLET / ORAL	RLD	2005-04-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021762-002	FOSAMAX PLUS D	EQ 70MG BASE;5,600 IU	TABLET / ORAL	RLD, RS	2007-04-26	`bb7c543d1eb4…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021762-001	5994329*PED	2019-01-17	Pediatric extension	`ea99ee380514…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-0270-44	EA - Each	0006-0270	d0d9adbc-ff6e-4e44-9626-6bfb8541344b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALENDRONATE SODIUM	ACTIVE INGREDIENT	2UY4M2U3RA	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
CHOLECALCIFEROL	ACTIVE INGREDIENT	1C6V77QF41	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
ALENDRONIC ACID	ACTIVE MOIETY	X1J18R4W8P	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
CHOLECALCIFEROL	ACTIVE MOIETY	1C6V77QF41	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
SODIUM ALUMINIUM SILICATE	INACTIVE INGREDIENT	058TS43PSM	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [MERCK SHARP & DOHME CORP.]	25

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 PLUS D	ALENDRONATE SODIUM AND CHOLECALCIFEROL	Organon LLC	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	2026-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021762 application number: NDA021762

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2UY4M2U3RA	ALENDRONATE SODIUM	121268-17-5	ALENDRONATE SODIUM
1C6V77QF41	CHOLECALCIFEROL	67-97-0	CHOLECALCIFEROL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0006-0270-21	00006027021	2 BLISTER PACK in 1 CARTON (0006-0270-21) > 10 TABLET in 1 BLISTER PACK (0006-0270-01)	2 blister pack	2005-04-07	0000-00-00	No	No	Current
0006-0270-44	00006027044	4 TABLET in 1 BLISTER PACK (0006-0270-44)	4 tablet	2005-04-07	0000-00-00	No	No	Current