Alendronate Sodium

Product NDC
16714-632
11-digit product format
167140632
Labeler code
16714
Product ID
16714-632_7e91c532-463d-4abd-96e9-08f5207db1c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alendronate Sodium
Dosage form
TABLET
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA090124
Marketing category
ANDA
Marketing start
2008-08-04
Substance
ALENDRONATE SODIUM
Active strength
35 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
A090124-001ALENDRONATE SODIUMALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04
A090124-002ALENDRONATE SODIUMALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04
A090124-003ALENDRONATE 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
A090124-001AB
A090124-002AB
A090124-003AB

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 UTC2026-02A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04d06236e962d9…
2024-10-29 15:01 UTC2024-10A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-0479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-04301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090124-001ALENDRONATE SODIUMEQ 10MG BASETABLET / ORALAB2008-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090124-002ALENDRONATE SODIUMEQ 35MG BASETABLET / ORALAB2008-08-041e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090124-003ALENDRONATE SODIUMEQ 70MG BASETABLET / ORALAB2008-08-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090124-001ALENDRONATE SODIUMEQ 10MG 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 UTC2026-02A090124-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090124-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090124-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090124-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090124-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090124-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090124-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090124-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090124-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090124-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090124-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090124-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090124-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090124-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090124-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090124-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090124-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090124-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090124-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090124-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090124-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090124-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090124-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090124-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090124-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090124-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090124-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090124-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090124-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090124-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090124-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090124-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090124-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090124-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090124-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090124-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090124-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090124-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090124-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090124-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Alendronate Sodium
Listing expiration
2027-12-31

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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
904396Internal RxNorm lookup
904419Internal 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
4323d3aa-cbb0-41e2-aba7-7a94a0516993Available 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
16714-632-01Alendronate Sodium4 in 1 BLISTER PACKTABLET416
16714-632-01Alendronate Sodium1 in 1 CARTONTABLET116
16714-632-02Alendronate Sodium5 in 1 CARTONTABLET516
16714-632-02Alendronate Sodium4 in 1 BLISTER PACKTABLET416
16714-632-10Alendronate Sodium10 in 1 BLISTER PACKTABLET1016
16714-632-11Alendronate Sodium10 in 1 CARTONTABLET1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-632-01EA - Each16714-6322dcca6ca-d5fb-4ee5-9dc8-1ec2596c8f8212012-07-24
16714-632-02EA - Each16714-6321413cf6a-ce51-43e0-bd69-c214ad14c5a812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALENDRONATE SODIUMACTIVE INGREDIENT2UY4M2U3RAALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
ALENDRONIC ACIDACTIVE MOIETYX1J18R4W8PALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
POVIDONE K30INACTIVE INGREDIENTU725QWY32XALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-632ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]15Current NDC, Legacy NDC, 6 package rows20240426_4323d3aa-cbb0-41e2-aba7-7a94a0516993.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alendronate SodiumALENDRONATE SODIUMRising Pharma Holdings, Inc.ffdd2496-d253-419b-85a6-8c615f7545f12026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124
Alendronate SodiumALENDRONATE SODIUMNorthStar Rx LLC4323d3aa-cbb0-41e2-aba7-7a94a05169932026-06-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124
ndc (product): 16714-632
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutionsd52cf007-5775-4dea-9f43-b1907b6ffe812026-05-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124
Alendronate SodiumALENDRONATE SODIUMAurobindo Pharma Limited815a87c4-e489-4eb9-9a2e-fb7a16642f012026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutionseeb65442-6b3c-485c-9c5d-9cf40df4451e2026-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124
Alendronate SodiumALENDRONATE SODIUMA-S Medication Solutions873442b0-1932-4fa6-ba25-b4d3505f41282024-11-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124
Alendronate SodiumALENDRONATE SODIUMProficient Rx LP6c4d13fb-490c-4ea9-9b04-003c8d8e9f0c2023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090124
application number: ANDA090124

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904419alendronate sodium 10 MG Oral TabletPSN4323d3aa-cbb0-41e2-aba7-7a94a051699316
904396alendronate sodium 35 MG Oral TabletPSN4323d3aa-cbb0-41e2-aba7-7a94a051699316
904431alendronate sodium 70 MG Oral TabletPSN4323d3aa-cbb0-41e2-aba7-7a94a051699316
904419alendronic acid 10 MG Oral TabletSCD4323d3aa-cbb0-41e2-aba7-7a94a051699316
904396alendronic acid 35 MG Oral TabletSCD4323d3aa-cbb0-41e2-aba7-7a94a051699316
904431alendronic acid 70 MG Oral TabletSCD4323d3aa-cbb0-41e2-aba7-7a94a051699316
904419alendronic acid 10 MG (as alendronate sodium 13.1 MG) Oral TabletSY4323d3aa-cbb0-41e2-aba7-7a94a051699316
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY4323d3aa-cbb0-41e2-aba7-7a94a051699316
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSY4323d3aa-cbb0-41e2-aba7-7a94a051699316
904396alendronate sodium 35 MG Oral TabletPSN873442b0-1932-4fa6-ba25-b4d3505f41285
904396alendronic acid 35 MG Oral TabletSCD873442b0-1932-4fa6-ba25-b4d3505f41285
904396alendronic acid 35 MG (as alendronate sodium 45.7 MG) Oral TabletSY873442b0-1932-4fa6-ba25-b4d3505f41285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-632-01167140632011 BLISTER PACK in 1 CARTON (16714-632-01) / 4 TABLET in 1 BLISTER PACK1 blister pack2008-08-040000-00-00NoNoCurrent
16714-632-02167140632025 BLISTER PACK in 1 CARTON (16714-632-02) / 4 TABLET in 1 BLISTER PACK5 blister pack2008-08-040000-00-00NoNoCurrent
16714-632-101671406321010 in 1 BLISTER PACKHistorical
16714-632-111671406321110 BLISTER PACK in 1 CARTON (16714-632-11) / 10 TABLET in 1 BLISTER PACK (16714-632-10) 10 blister pack2008-08-040000-00-00NoNoCurrent