ALENDRONATE SODIUM

Product NDC
70518-0033
11-digit product format
705180033
Labeler code
70518
Product ID
70518-0033_4cd5394f-5f36-4207-e063-6394a90a76f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate sodium
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076768
Marketing category
ANDA
Marketing start
2016-12-01
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 packagepackage70518-003370518-0033-1DDiscontinued by firm2026-08-10

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 · 12 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…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
ALENDRONATE SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM70 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2UY4M2U3RAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904431Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c4358ba7-1bf8-4b0a-9407-5ac279d04555Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0033-0ALENDRONATE SODIUM12 in 1 BLISTER PACKTABLET1222
70518-0033-1ALENDRONATE SODIUM12 in 1 BOTTLE, PLASTICTABLET1222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-0033-0EA - Each70518-00331663f18b-5d03-4237-b079-9543c52a85b112025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0033ALENDRONATE SODIUM TABLET [REMEDYREPACK INC.]18Current NDC, Legacy NDC, 2 package rows20250524_c4358ba7-1bf8-4b0a-9407-5ac279d04555.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
ndc (product): 70518-0033
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
904431alendronate sodium 70 MG Oral TabletPSNc4358ba7-1bf8-4b0a-9407-5ac279d0455522
904431alendronic acid 70 MG Oral TabletSCDc4358ba7-1bf8-4b0a-9407-5ac279d0455522
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYc4358ba7-1bf8-4b0a-9407-5ac279d0455522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0033-07051800330012 TABLET in 1 BLISTER PACK (70518-0033-0) 12 tablet2016-12-010000-00-00NoNoCurrent
70518-0033-17051800330112 TABLET in 1 BOTTLE, PLASTIC (70518-0033-1) 12 tablet2018-04-120000-00-00NoNoCurrent