alendronate sodium

Product NDC
50090-1091
11-digit product format
500901091
Labeler code
50090
Product ID
50090-1091_2ebcc844-dc8c-43cc-83e2-09254cfb47e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076984
Marketing category
ANDA
Marketing start
2009-10-23
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-1091IInactivated by FDA2026-08-10
excluded packagepackage50090-109150090-1091-0IInactivated by FDA2026-08-10

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-1091-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-1091-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-1091-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-1091-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-1091-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-1091-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-1091-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-1091-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-1091-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-1091-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-1091-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-1091-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-1091-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-1091-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-1091-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-1091-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-1091-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-1091-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-1091-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-1091-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-1091-09bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076984-001ALENDRONATE SODIUMALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04
A076984-002ALENDRONATE SODIUMALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04
A076984-003ALENDRONATE SODIUMALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076984-001AB
A076984-002AB
A076984-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076984-002ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076984-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076984-001ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-048072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076984-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076984-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076984-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076984-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076984-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076984-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076984-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076984-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076984-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076984-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076984-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076984-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076984-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076984-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076984-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076984-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076984-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076984-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076984-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076984-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076984-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076984-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076984-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076984-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076984-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076984-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076984-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076984-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076984-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A076984-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076984-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076984-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076984-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076984-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076984-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076984-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076984-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076984-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076984-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076984-001AB18072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1091-0alendronate sodium4 in 1 BLISTER PACKTABLET48
50090-1091-0alendronate sodium1 in 1 BOX, UNIT-DOSETABLET18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1091-0EA - Each50090-1091e6c61c1f-c906-421a-a622-c56894e427c212018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1091ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20180828_532987e4-cfe5-4902-9ea9-6555b101548c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN532987e4-cfe5-4902-9ea9-6555b101548c8
904431alendronate sodium 70 MG Oral TabletPSN532987e4-cfe5-4902-9ea9-6555b101548c8
904396alendronic acid 35 MG Oral TabletSCD532987e4-cfe5-4902-9ea9-6555b101548c8
904431alendronic acid 70 MG Oral TabletSCD532987e4-cfe5-4902-9ea9-6555b101548c8
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY532987e4-cfe5-4902-9ea9-6555b101548c8
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY532987e4-cfe5-4902-9ea9-6555b101548c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1091-0500901091004 in 1 BLISTER PACKHistorical