Alendronate

Product NDC
60723-207
Requested package NDC
60723-207-01
11-digit product format
607230207
Labeler code
60723
Product ID
60723-207_460d461d-4807-2ed0-e063-6394a90aad4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALENDRONATE SODIUM
Dosage form
TABLET
Route
ORAL
Labeler
Hangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.
Application
ANDA090258
Marketing category
ANDA
Marketing start
2017-12-05
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
unfinished packagepackage60723-20760723-207-01UNFINISHEDActive or certified unfinished drug listing2026-08-12

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 · 21 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 21:27 UTC · source 2025-12-05a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-261d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-1768b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-2905c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-0848b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-0827f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-098d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-1450b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-276db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-188fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-174184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-104bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-305b2001dcd8f5…54b53d4dc9e4…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Alendronate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM35 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904396Internal RxNorm lookup
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
a24fd39c-34a7-4de2-9439-781e612189caAvailable 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
60723-207-31Alendronate4 in 1 BLISTER PACKTABLET427
60723-207-31Alendronate1 in 1 CARTONTABLET127
60723-207-32Alendronate4 in 1 BLISTER PACKTABLET427
60723-207-32Alendronate3 in 1 CARTONTABLET327
60723-207-33Alendronate10 in 1 BLISTER PACKTABLET1027
60723-207-33Alendronate2 in 1 CARTONTABLET227

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60723-207ALENDRONATE (ALENDRONATE SODIUM) TABLET [HANGZHOU MINSHENG BINJIANG PHARMACEUTICAL CO., LTD.]26Current NDC, Legacy NDC, 6 package rows20241123_a24fd39c-34a7-4de2-9439-781e612189ca.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
ndc (product): 60723-207
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 TabletPSNa24fd39c-34a7-4de2-9439-781e612189ca27
904431alendronate sodium 70 MG Oral TabletPSNa24fd39c-34a7-4de2-9439-781e612189ca27
904396alendronic acid 35 MG Oral TabletSCDa24fd39c-34a7-4de2-9439-781e612189ca27
904431alendronic acid 70 MG Oral TabletSCDa24fd39c-34a7-4de2-9439-781e612189ca27
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSYa24fd39c-34a7-4de2-9439-781e612189ca27
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYa24fd39c-34a7-4de2-9439-781e612189ca27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startStatus
60723-207-01607230207011 BAG in 1 CASE (60723-207-01) / 80000 TABLET in 1 BAG1 bag25-JAN-18Current