Alendronate

Product NDC
10135-697
Requested package NDC
10135-697-20
11-digit product format
101350697
Labeler code
10135
Product ID
10135-697_76e6ead3-9532-4206-ad5f-a4a8a1eba934
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA090258
Marketing category
ANDA
Marketing start
2020-03-01
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC],Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage10135-69710135-697-20IInactivated 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 · 18 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…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090258-001ALENDRONATE SODIUMALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-24
A090258-002ALENDRONATE SODIUMALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-24
A090258-003ALENDRONATE SODIUMALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-24
A090258-004ALENDRONATE SODIUMALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090258-001AB
A090258-002AB
A090258-003AB
A090258-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090258-001ALENDRONATE SODIUMEQ 5MG BASETABLET / ORALAB2009-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A090258-002ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2009-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A090258-003ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2009-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A090258-004ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2009-09-24d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090258-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090258-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090258-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090258-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090258-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090258-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090258-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090258-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090258-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090258-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090258-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090258-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090258-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090258-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090258-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090258-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090258-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090258-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090258-004AB1d06236e962d9…

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
10135-697-12Alendronate3 in 1 CARTONTABLET31
10135-697-12Alendronate4 in 1 BLISTER PACKTABLET41
10135-697-20Alendronate10 in 1 BLISTER PACKTABLET101
10135-697-20Alendronate2 in 1 CARTONTABLET21
10135-697-44Alendronate4 in 1 BLISTER PACKTABLET41
10135-697-44Alendronate1 in 1 CARTONTABLET11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-697-12EA - Each10135-69750c40f4a-fc15-4f28-898d-af777b8fc7c112020-05-08
10135-697-20EA - Each10135-697f89fd345-558d-4520-ba90-66b32d45e15c12020-05-08
10135-697-44EA - Each10135-69770f5bd3c-8372-449a-a82f-68331f902a0512020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-697ALENDRONATE (ALENDRONATE SODIUM) TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 6 package rows20200410_c1e61b54-287f-47ed-9192-e3c98ecb2e06.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.a24fd39c-34a7-4de2-9439-781e612189ca2025-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090258
application number: ANDA090258
AlendronateALENDRONATE SODIUM TABLETMarlex Pharmaceuticals, Inc.b63421af-ec03-1de7-e053-2a95a90abec62025-09-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090258
application number: ANDA090258

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904396alendronate sodium 35 MG Oral TabletPSNc1e61b54-287f-47ed-9192-e3c98ecb2e061
904431alendronate sodium 70 MG Oral TabletPSNc1e61b54-287f-47ed-9192-e3c98ecb2e061
904396alendronic acid 35 MG Oral TabletSCDc1e61b54-287f-47ed-9192-e3c98ecb2e061
904431alendronic acid 70 MG Oral TabletSCDc1e61b54-287f-47ed-9192-e3c98ecb2e061
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYc1e61b54-287f-47ed-9192-e3c98ecb2e061
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYc1e61b54-287f-47ed-9192-e3c98ecb2e061

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-697-20101350697202 BLISTER PACK in 1 CARTON (10135-697-20) > 10 TABLET in 1 BLISTER PACK2 blister pack2020-03-010000-00-00NoNoCurrent