FOSAMAX PLUS D

Product NDC: 78206-136
11-digit product format: 782060136
Labeler code: 78206
Product ID: 78206-136_10aeb309-f6e1-49c6-ac6f-ad743db28527
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ALENDRONATE SODIUM and CHOLECALCIFEROL
Dosage form: TABLET
Route: ORAL
Labeler: Organon LLC
Application: NDA021762
Marketing category: NDA
Marketing start: 2021-06-01
Substance: ALENDRONATE SODIUM; CHOLECALCIFEROL
Active strength: 70; 5600 mg/1; [iU]/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS], Vitamin D [CS], Vitamin D [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: FOSAMAX PLUS D
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALENDRONATE SODIUM	70 mg/1
CHOLECALCIFEROL	5600 [iU]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2UY4M2U3RA	Internal UNII lookup
1C6V77QF41	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904462	Internal RxNorm lookup
904465	Internal RxNorm lookup
904492	Internal RxNorm lookup
904495	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
78206-136-01	FOSAMAX PLUS D	4 in 1 BLISTER PACK	TABLET	4		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
78206-136-01	EA - Each	78206-136	f770244d-b705-4465-8a7a-9b8676d16b9d	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-136	FOSAMAX PLUS D (ALENDRONATE SODIUM AND CHOLECALCIFEROL) TABLET [ORGANON LLC]	6	Current NDC, Legacy NDC, 1 package rows	20240418_10307e7e-9a84-4aa1-8c5c-4b209cffe4d1.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 · 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 ndc (product): 78206-136

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
904492	alendronate sodium 70 MG / cholecalciferol 2800 UNT Oral Tablet	PSN	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904462	alendronate sodium 70 MG / cholecalciferol 5600 UNT Oral Tablet	PSN	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904495	FOSAMAX PLUS D 70 MG / 2800 UNT Oral Tablet	PSN	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904465	FOSAMAX PLUS D 70 MG / 5600 UNT Oral Tablet	PSN	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904495	alendronic acid 70 MG / cholecalciferol 2800 UNT Oral Tablet [Fosamax Plus D]	SBD	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904465	alendronic acid 70 MG / cholecalciferol 5600 UNT Oral Tablet [Fosamax Plus D]	SBD	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904492	alendronic acid 70 MG / cholecalciferol 2800 UNT Oral Tablet	SCD	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904462	alendronic acid 70 MG / cholecalciferol 5600 UNT Oral Tablet	SCD	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904492	alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 2800 UNT Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904462	alendronic acid 70 MG (as alendronate sodium 91.4 MG) / cholecalciferol 5600 UNT Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904492	alendronic acid 70 MG / vitamin D3 2800 UNT Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904462	alendronic acid 70 MG / vitamin D3 5,600 UNT Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904495	Fosamax Plus D 70/2800 (alendronic acid / vitamin D3) Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904495	Fosamax Plus D 70/2800 Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904465	Fosamax Plus D 70/5600 (alendronic acid / vitamin D3) Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10
904465	Fosamax Plus D 70/5600 Oral Tablet	SY	10307e7e-9a84-4aa1-8c5c-4b209cffe4d1	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-136-01	78206013601	4 TABLET in 1 BLISTER PACK (78206-136-01)	4 tablet	2021-06-01	0000-00-00	No	No	Current