Alendronate Sodium

Product NDC: 64980-341
11-digit product format: 649800341
Labeler code: 64980
Product ID: 64980-341_ac73eca3-eeb7-4be7-9b03-471c4941e5e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Rising Pharma Holdings, Inc.
Application: ANDA090124
Marketing category: ANDA
Marketing start: 2008-08-04
Substance: ALENDRONATE SODIUM
Active strength: 35 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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090124-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04
A090124-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04
A090124-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090124-001	AB
A090124-002	AB
A090124-003	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 4 · 123 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	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-003	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	A090124-001	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	A090124-002	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	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-003	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	A090124-001	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	A090124-002	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	A090124-003	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	A090124-001	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	A090124-002	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	A090124-003	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	A090124-001	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	A090124-002	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	A090124-003	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	A090124-001	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	A090124-002	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	A090124-003	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	A090124-001	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	A090124-002	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	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-002	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-003	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	AB	2008-08-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090124-001	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	AB	2008-08-04	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090124-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090124-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090124-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090124-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090124-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090124-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090124-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090124-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090124-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090124-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090124-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090124-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090124-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090124-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090124-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090124-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090124-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALENDRONATE SODIUM	35 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904396	Internal RxNorm lookup
904419	Internal RxNorm lookup
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
ffdd2496-d253-419b-85a6-8c615f7545f1	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
64980-341-12	Alendronate Sodium	3 in 1 CARTON	TABLET	3	6
64980-341-12	Alendronate Sodium	4 in 1 BLISTER PACK	TABLET	4	6
64980-341-14	Alendronate Sodium	4 in 1 BLISTER PACK	TABLET	4	6
64980-341-14	Alendronate Sodium	1 in 1 CARTON	TABLET	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64980-341-14	EA - Each	64980-341	4df10a09-b561-4226-bec2-c36046d0b7fe	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64980-341	ALENDRONATE SODIUM TABLET [RISING PHARMA HOLDINGS, INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240510_ffdd2496-d253-419b-85a6-8c615f7545f1.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alendronate Sodium	ALENDRONATE SODIUM	Rising Pharma Holdings, Inc.	ffdd2496-d253-419b-85a6-8c615f7545f1	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124 ndc (product): 64980-341
Alendronate Sodium	ALENDRONATE SODIUM	NorthStar Rx LLC	4323d3aa-cbb0-41e2-aba7-7a94a0516993	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	d52cf007-5775-4dea-9f43-b1907b6ffe81	2026-05-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	Aurobindo Pharma Limited	815a87c4-e489-4eb9-9a2e-fb7a16642f01	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	eeb65442-6b3c-485c-9c5d-9cf40df4451e	2026-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	A-S Medication Solutions	873442b0-1932-4fa6-ba25-b4d3505f4128	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124
Alendronate Sodium	ALENDRONATE SODIUM	Proficient Rx LP	6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c	2023-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090124 application number: ANDA090124

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	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904396	alendronate sodium 35 MG Oral Tablet	PSN	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904431	alendronate sodium 70 MG Oral Tablet	PSN	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904419	alendronic acid 10 MG Oral Tablet	SCD	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904396	alendronic acid 35 MG Oral Tablet	SCD	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904431	alendronic acid 70 MG Oral Tablet	SCD	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904419	alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral Tablet	SY	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904396	alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet	SY	ffdd2496-d253-419b-85a6-8c615f7545f1	6
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	ffdd2496-d253-419b-85a6-8c615f7545f1	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
64980-341-12	64980034112	3 BLISTER PACK in 1 CARTON (64980-341-12) / 4 TABLET in 1 BLISTER PACK	3 blister pack	2008-08-04	0000-00-00	No	No	Current
64980-341-14	64980034114	1 BLISTER PACK in 1 CARTON (64980-341-14) / 4 TABLET in 1 BLISTER PACK	1 blister pack	2008-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alendronate Sodium	Rising Pharma Holdings, Inc. \| Aurobindo Pharma Limited	2026-06-12	Human Prescription Drug Label	7