Alendronate Sodium

Product NDC: 0115-1678
11-digit product format: 001151678
Labeler code: 0115
Product ID: 0115-1678_0bb7b70c-72e0-4bb8-9d3a-0fc8e4762dd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Alendronate Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA075710
Marketing category: ANDA
Marketing start: 2008-02-06
Substance: ALENDRONATE SODIUM
Active strength: 10 mg/1
Pharmacologic classes: Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product	0115-1678		I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1678	0115-1678-01	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0115-1678	0115-1678-08	I	Inactivated by FDA	excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`

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	Approval date
A075710-001	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06
A075710-002	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06
A075710-003	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06
A075710-004	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06
A075710-005	ALENDRONATE SODIUM	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-001	ALENDRONATE SODIUM	EQ 5MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-002	ALENDRONATE SODIUM	EQ 10MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-003	ALENDRONATE SODIUM	EQ 35MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-004	ALENDRONATE SODIUM	EQ 40MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075710-005	ALENDRONATE SODIUM	EQ 70MG BASE	TABLET / ORAL	2008-02-06	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075710-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075710-005	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075710-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075710-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A075710-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075710-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A075710-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075710-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A075710-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075710-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075710-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075710-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075710-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075710-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075710-005	AB	1	`ea99ee380514…`

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	10 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
904396	Internal RxNorm lookup
904405	Internal RxNorm lookup
904419	Internal RxNorm lookup
904425	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
c23fb7fe-c6b9-4f77-bde7-992222b589d3	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0115-1678-01	2020-12-29	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-08	2020-12-29	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-01	2020-09-27	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-08	2020-09-27	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-01	2020-09-25	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-08	2020-09-25	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-01	2020-07-22	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995
0115-1678-08	2020-07-22	These highlights do not include all the information needed to use ALENDRONATE SODIUM TABLETS safely and effectively. See full prescribing information for ALENDRONATE SODIUM TABLETS. ALENDRONATE SODIUM tablets, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0115-1678-01	Alendronate Sodium	100 in 1 BOTTLE	TABLET	100		40
0115-1678-08	Alendronate Sodium	30 in 1 BOTTLE	TABLET	30		40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1678-01	EA - Each	0115-1678	99c70f68-9b94-4ee7-b4d6-6a51aeddf2c3	1	2017-03-06
0115-1678-08	EA - Each	0115-1678	fbcf096c-13b7-4648-9ea0-f80c75cd09aa	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0115-1678	ALENDRONATE SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	40	Current NDC, Legacy NDC, 2 package rows	20231231_c23fb7fe-c6b9-4f77-bde7-992222b589d3.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
Alendronate Sodium	ALENDRONATE SODIUM	Amneal Pharmaceuticals of New York LLC	c23fb7fe-c6b9-4f77-bde7-992222b589d3	2021-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075710 application number: ANDA075710 ndc (product): 0115-1678

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	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904396	alendronate sodium 35 MG Oral Tablet	PSN	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904405	alendronate sodium 40 MG Oral Tablet	PSN	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904425	alendronate sodium 5 MG Oral Tablet	PSN	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904431	alendronate sodium 70 MG Oral Tablet	PSN	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904419	alendronic acid 10 MG Oral Tablet	SCD	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904396	alendronic acid 35 MG Oral Tablet	SCD	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904405	alendronic acid 40 MG Oral Tablet	SCD	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904425	alendronic acid 5 MG Oral Tablet	SCD	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904431	alendronic acid 70 MG Oral Tablet	SCD	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904419	alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral Tablet	SY	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904396	alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral Tablet	SY	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904405	alendronic acid 40 MG (as alendronate sodium 52.21 MG) Oral Tablet	SY	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904425	alendronic acid 5 MG (as alendronate sodium 6.53 MG) Oral Tablet	SY	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40
904431	alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral Tablet	SY	c23fb7fe-c6b9-4f77-bde7-992222b589d3	40

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0115-1678-01	00115167801	100 TABLET in 1 BOTTLE (0115-1678-01)	100 tablet	2008-02-06	0000-00-00	No	No	Current
0115-1678-08	00115167808	30 TABLET in 1 BOTTLE (0115-1678-08)	30 tablet	2008-02-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alendronate Sodium	Amneal Pharmaceuticals of New York LLC	2021-02-02	HUMAN PRESCRIPTION DRUG LABEL	40