ALENDRONATE SODIUM

Product NDC
50090-4076
Requested package NDC
50090-4076-0
11-digit product format
500904076
Labeler code
50090
Product ID
50090-4076_aff05ead-3677-44df-ad8f-4120542086ab
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
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
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-407650090-4076-0IInactivated 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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076768-001ALENDRONATE SODIUMALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04
A076768-002ALENDRONATE SODIUMALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04
A076768-003ALENDRONATE SODIUMALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04
A076768-004ALENDRONATE SODIUMALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04
A076768-005ALENDRONATE SODIUMALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076768-001AB
A076768-002AB
A076768-003AB
A076768-004AB
A076768-005AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-004ALENDRONATE SODIUMEQ 40MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-005ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A076768-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076768-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076768-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076768-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076768-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076768-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076768-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076768-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076768-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076768-005AB15bbf6a4d5a75…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4076-0ALENDRONATE SODIUM1 in 1 CARTONTABLET15
50090-4076-0ALENDRONATE SODIUM4 in 1 BLISTER PACKTABLET45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4076-0EA - Each50090-4076f758d694-f7bf-4f85-9829-b1e2c7d934b212022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4076ALENDRONATE SODIUM TABLET [A-S MEDICATION SOLUTIONS]5Legacy NDC, 2 package rows20210418_00d7c0c2-8f16-4c99-86d4-d7a53191f2c7.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c7e470d6-508e-466e-a78d-060bbbc9745c2026-07-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.54d6543d-4239-58b1-e054-00144ff88e882026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c4358ba7-1bf8-4b0a-9407-5ac279d045552026-06-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMCipla USA Inc.e2fac28d-ad91-4cdc-a003-9fdeac073f762026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMPreferred Pharmaceuticals Inc.83e3ba94-d882-4b5c-87cb-af1eb0997efc2026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMA-S Medication Solutionsfe1dd324-eb02-4a73-97f5-9b77a7df10a72025-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals, Inc.2baf8516-4148-9007-e063-6394a90a80942025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768
ALENDRONATE SODIUMALENDRONATE SODIUMEXELAN PHARMACEUTICALS INC.91a0f73a-d8cd-4197-b431-40707a2150b92023-08-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076768
application number: ANDA076768

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSN00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronic acid 35 MG Oral TabletSCD00d7c0c2-8f16-4c99-86d4-d7a53191f2c75
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY00d7c0c2-8f16-4c99-86d4-d7a53191f2c75

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4076-0500904076001 BLISTER PACK in 1 CARTON (50090-4076-0) > 4 TABLET in 1 BLISTER PACK1 blister pack2019-01-220000-00-00NoNoCurrent