ALENDRONATE SODIUM

Product NDC: 50090-4692
Requested package NDC: 50090-4692-0
11-digit product format: 500904692
Labeler code: 50090
Product ID: 50090-4692_789fd89e-ccc6-4b79-9611-c35fa3061ba7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate sodium
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA076768
Marketing category: ANDA
Marketing start: 2008-08-04
Substance: ALENDRONATE SODIUM
Active strength: 70 mg/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	Approval date
A076768-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04
A076768-005	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A076768-001	AB
A076768-002	AB
A076768-003	AB
A076768-004	AB
A076768-005	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A076768-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076768-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076768-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076768-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076768-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076768-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076768-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076768-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076768-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076768-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

Finished product: Yes
Brand name base: ALENDRONATE SODIUM
Listing expiration: 2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904431	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
fe1dd324-eb02-4a73-97f5-9b77a7df10a7	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	SPL version
50090-4692-0	ALENDRONATE SODIUM	4 in 1 BLISTER PACK	TABLET	4	12
50090-4692-0	ALENDRONATE SODIUM	1 in 1 CARTON	TABLET	1	12
50090-4692-1	ALENDRONATE SODIUM	3 in 1 CARTON	TABLET	3	12
50090-4692-1	ALENDRONATE SODIUM	4 in 1 BLISTER PACK	TABLET	4	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-4692-0	EA - Each	50090-4692	34978e17-9a5b-493d-a35f-c1bff8c747ba	1	2022-12-07
50090-4692-1	EA - Each	50090-4692	1b939c5a-27f6-41c2-8b2e-895a51c9f443	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-4692	ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]	10	Current NDC, Legacy NDC, 4 package rows	20231026_fe1dd324-eb02-4a73-97f5-9b77a7df10a7.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c7e470d6-508e-466e-a78d-060bbbc9745c	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals,Inc.	54d6543d-4239-58b1-e054-00144ff88e88	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	REMEDYREPACK INC.	c4358ba7-1bf8-4b0a-9407-5ac279d04555	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Cipla USA Inc.	e2fac28d-ad91-4cdc-a003-9fdeac073f76	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	Preferred Pharmaceuticals Inc.	83e3ba94-d882-4b5c-87cb-af1eb0997efc	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	A-S Medication Solutions	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768 ndc (package): 50090-4692-0 ndc (product): 50090-4692 ndc11 (package): 50090469200
ALENDRONATE SODIUM	ALENDRONATE SODIUM	NuCare Pharmaceuticals, Inc.	2baf8516-4148-9007-e063-6394a90a8094	2025-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768
ALENDRONATE SODIUM	ALENDRONATE SODIUM	EXELAN PHARMACEUTICALS INC.	91a0f73a-d8cd-4197-b431-40707a2150b9	2023-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076768 application number: ANDA076768

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	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	12
904431	alendronic acid 70 MG Oral Tablet	SCD	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	12
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	fe1dd324-eb02-4a73-97f5-9b77a7df10a7	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-4692-0	50090469200	1 BLISTER PACK in 1 CARTON (50090-4692-0) / 4 TABLET in 1 BLISTER PACK	1 blister pack	2019-11-07	0000-00-00	No	No	Current