FDA.reportPublic FDA data

Alendronate Sodium

Product NDC
16714-633
11-digit product format
167140633
Labeler code
16714
Product ID
16714-633_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
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui904396, 904419, 904431

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
16714-633-01Alendronate Sodium1 in 1 CARTONTABLET116
16714-633-01Alendronate Sodium4 in 1 BLISTER PACKTABLET416
16714-633-02Alendronate Sodium5 in 1 CARTONTABLET516
16714-633-02Alendronate Sodium4 in 1 BLISTER PACKTABLET416
16714-633-10Alendronate Sodium10 in 1 BLISTER PACKTABLET1016
16714-633-11Alendronate Sodium10 in 1 CARTONTABLET1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-633-01EA - Each16714-63351e3e739-ec12-4ab4-861e-c5e74487224512012-07-24
16714-633-02EA - Each16714-633b1a42e05-247c-4807-92aa-f4353f95a87212012-07-24

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
16714-633ALENDRONATE SODIUM TABLET [NORTHSTAR RX LLC]15Current NDC, Legacy NDC, 6 package rows20240426_4323d3aa-cbb0-41e2-aba7-7a94a0516993.zip

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
904431alendronate sodium 70 MG Oral TabletPSNd52cf007-5775-4dea-9f43-b1907b6ffe8111
904431alendronic acid 70 MG Oral TabletSCDd52cf007-5775-4dea-9f43-b1907b6ffe8111
904431alendronic acid 70 MG (as alendronate sodium 91.4 MG) Oral TabletSYd52cf007-5775-4dea-9f43-b1907b6ffe8111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16714-633-01167140633011 BLISTER PACK in 1 CARTON (16714-633-01) / 4 TABLET in 1 BLISTER PACK1 blister pack2008-08-040000-00-00NoNoCurrent
16714-633-02167140633025 BLISTER PACK in 1 CARTON (16714-633-02) / 4 TABLET in 1 BLISTER PACK5 blister pack2008-08-040000-00-00NoNoCurrent
16714-633-101671406331010 in 1 BLISTER PACKHistorical
16714-633-111671406331110 BLISTER PACK in 1 CARTON (16714-633-11) / 10 TABLET in 1 BLISTER PACK (16714-633-10) 10 blister pack2008-08-040000-00-00NoNoCurrent