FOSAMAX

Product NDC: 78206-135
Requested package NDC: 78206-135-01
11-digit product format: 782060135
Labeler code: 78206
Product ID: 78206-135_1013aa0b-071e-46c4-8bed-207bb10ac2fd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: alendronate sodium
Dosage form: TABLET
Route: ORAL
Labeler: Organon LLC
Application: NDA020560
Marketing category: NDA
Marketing start: 2021-06-01
Substance: ALENDRONATE SODIUM
Active strength: 70 mg/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
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 43.

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N020560-001	FOSAMAX	ALENDRONATE SODIUM	EQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29
N020560-002	FOSAMAX	ALENDRONATE SODIUM	EQ 40MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1995-09-29
N020560-003	FOSAMAX	ALENDRONATE SODIUM	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-04-25
N020560-004	FOSAMAX	ALENDRONATE SODIUM	EQ 35MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2000-10-20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 · 215 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
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	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	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	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	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020560-005	FOSAMAX	EQ 70MG BASE	TABLET / ORAL	AB	RLD, RS	2000-10-20	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N020560-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020560-005	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALENDRONATE SODIUM	70 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904431	Internal RxNorm lookup
904433	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
14e931fd-2c5f-4d90-b7db-5980706f4a56	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
78206-135-01	FOSAMAX	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
78206-135-01	EA - Each	78206-135	cf348212-280a-44a3-859c-6fa33ea085bf	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78206-135	FOSAMAX (ALENDRONATE SODIUM) TABLET [ORGANON LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240418_14e931fd-2c5f-4d90-b7db-5980706f4a56.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	ALENDRONATE SODIUM	Organon LLC	14e931fd-2c5f-4d90-b7db-5980706f4a56	2026-03-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020560 application number: NDA020560 ndc (package): 78206-135-01 ndc (product): 78206-135 ndc11 (package): 78206013501

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
904431	alendronate sodium 70 MG Oral Tablet	PSN	14e931fd-2c5f-4d90-b7db-5980706f4a56	10
904433	FOSAMAX 70 MG Oral Tablet	PSN	14e931fd-2c5f-4d90-b7db-5980706f4a56	10
904433	alendronic acid 70 MG Oral Tablet [Fosamax]	SBD	14e931fd-2c5f-4d90-b7db-5980706f4a56	10
904431	alendronic acid 70 MG Oral Tablet	SCD	14e931fd-2c5f-4d90-b7db-5980706f4a56	10
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	14e931fd-2c5f-4d90-b7db-5980706f4a56	10
904433	Fosamax 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	14e931fd-2c5f-4d90-b7db-5980706f4a56	10
904433	Fosamax 70 MG Oral Tablet	SY	14e931fd-2c5f-4d90-b7db-5980706f4a56	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78206-135-01	78206013501	4 TABLET in 1 BLISTER PACK (78206-135-01)	4 tablet	2021-06-01	0000-00-00	No	No	Current