FDA.reportPublic FDA data

Binosto

Product NDC
17139-400
11-digit product format
171390400
Labeler code
17139
Product ID
17139-400_ec1bfaa8-1f9f-bd6f-e053-2a95a90a9b3e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alendronate sodium
Dosage form
TABLET, EFFERVESCENT
Route
ORAL
Labeler
ASCEND Therapeutics U.S., LLC
Application
NDA202344
Marketing category
NDA
Marketing start
2012-09-03
Marketing end
0000-00-00
Substance
ALENDRONATE SODIUM
Active strength
70 mg/1
Pharmacologic classes
Bisphosphonate [EPC], Diphosphonates [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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
17139-400-012025-01-30C16284748780-12cef2736-7860-d83d-e063-dadaa90ab31fBINOSTO (alendronate sodium) effervescent tablets for oral solution These 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
17139-400-042025-01-30C16284748780-12cef2736-7860-d83d-e063-dadaa90ab31fBINOSTO (alendronate sodium) effervescent tablets for oral solution These 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
17139-400-01Binosto1 in 1 CARTONTABLET, EFFERVESCENT123
17139-400-04Binosto4 in 1 CARTONTABLET, EFFERVESCENT423

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17139-400-00EA - Each17139-40019e2b147-c475-4499-a468-28e1797caa2212020-01-03
17139-400-04EA - Each17139-40096205f5f-4277-4ba0-8202-1fc2a29c148f12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17139-400BINOSTO (ALENDRONATE SODIUM) TABLET, EFFERVESCENT [ASCEND THERAPEUTICS]23Legacy NDC, 2 package rows20231221_b278a11a-b8d7-49f3-9b38-29b67c4c417e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248077alendronate sodium 70 MG Effervescent Oral TabletPSNb278a11a-b8d7-49f3-9b38-29b67c4c417e23
1248083Binosto 70 MG Effervescent Oral TabletPSNb278a11a-b8d7-49f3-9b38-29b67c4c417e23
1248083alendronic acid 70 MG Effervescent Oral Tablet [Binosto]SBDb278a11a-b8d7-49f3-9b38-29b67c4c417e23
1248077alendronic acid 70 MG Effervescent Oral TabletSCDb278a11a-b8d7-49f3-9b38-29b67c4c417e23
1248077alendronic acid (as alendronate sodium) 70 MG Effervescent Oral TabletSYb278a11a-b8d7-49f3-9b38-29b67c4c417e23
1248083Binoso (alendronic acid 70 MG (as alendronate sodium)) Effervescent Oral TabletSYb278a11a-b8d7-49f3-9b38-29b67c4c417e23
1248083Binosto 70 MG Effervescent Oral TabletSYb278a11a-b8d7-49f3-9b38-29b67c4c417e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17139-400-01171390400011 TABLET, EFFERVESCENT in 1 CARTON (17139-400-01) 2019-11-270000-00-00NoNoCurrent
17139-400-04171390400044 TABLET, EFFERVESCENT in 1 CARTON (17139-400-04) 2019-11-270000-00-00NoNoCurrent