FDA.reportPublic FDA data

Binosto

Product NDC
70539-400
11-digit product format
705390400
Labeler code
70539
Product ID
70539-400_1ff6288a-ab6b-4443-81bd-fd1a37a2bd16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
Radius Health, Inc.
Application
NDA202344
Marketing category
NDA
Marketing start
2012-03-12
Substance
ALENDRONATE SODIUM
Active strength
91.37 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
Binosto
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALENDRONATE SODIUM91.37 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2UY4M2U3RA
Rxcui1248077, 1248083

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b55122e7-1795-3be6-8216-d42256d80e7dProduct name220250224
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
c3d77bcb-5cf1-4ea6-9307-38d8932a8b0aProduct name120240513
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
c00e0569-fbc4-d31d-3ec8-d316fcedaffcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70539-400-042025-02-24C16284748780-12cef2736-85bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
70539-400-942025-02-24C16284748780-12cef2736-85bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
70539-400-042025-01-30C16284748780-12cef2736-85bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995
70539-400-942025-01-30C16284748780-12cef2736-85bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use BINOSTO ® safely and effectively. See full prescribing information for BINOSTO. BINOSTO (alendronate sodium) effervescent tablets for oral solution Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70539-400-00Binosto1 in 1 BLISTER PACKTABLET, EFFERVESCENT16
70539-400-04Binosto4 in 1 BOXTABLET, EFFERVESCENT46
70539-400-94Binosto4 in 1 BOXTABLET, EFFERVESCENT46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70539-400-00EA - Each70539-40034311e07-7589-4e70-8c5a-79051e6fecd412023-12-05
70539-400-04EA - Each70539-400df056e85-2af3-45ec-802b-99ef3cc1b8ca12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70539-400BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [RADIUS HEALTH, INC.]3Current NDC, 3 package rows20250226_09765234-01bc-40f7-b9bb-c167056f3909.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248077alendronate sodium 70 MG Effervescent Oral TabletPSN09765234-01bc-40f7-b9bb-c167056f39096
1248083Binosto 70 MG Effervescent Oral TabletPSN09765234-01bc-40f7-b9bb-c167056f39096
1248083alendronic acid 70 MG Effervescent Oral Tablet [Binosto]SBD09765234-01bc-40f7-b9bb-c167056f39096
1248077alendronic acid 70 MG Effervescent Oral TabletSCD09765234-01bc-40f7-b9bb-c167056f39096
1248077alendronic acid (as alendronate sodium) 70 MG Effervescent Oral TabletSY09765234-01bc-40f7-b9bb-c167056f39096
1248083Binoso (alendronic acid 70 MG (as alendronate sodium)) Effervescent Oral TabletSY09765234-01bc-40f7-b9bb-c167056f39096
1248083Binosto 70 MG Effervescent Oral TabletSY09765234-01bc-40f7-b9bb-c167056f39096

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70539-400-00705390400001 in 1 BLISTER PACKHistorical
70539-400-04705390400044 BLISTER PACK in 1 BOX (70539-400-04) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00) 4 blister pack2012-03-12NoNoCurrent
70539-400-94705390400944 BLISTER PACK in 1 BOX (70539-400-94) / 1 TABLET, EFFERVESCENT in 1 BLISTER PACK (70539-400-00) 4 blister pack2023-03-12NoNoCurrent