FDA.reportPublic FDA data

NDC 70539-400-00 - Binosto

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70539-400
Requested NDC
70539-400-00
Package NDCs from labels
70539-400-00, 70539-400-04, 70539-400-94
Manufacturer
Radius Health, Inc. | Polpharma S.A. | SwissCo Services AG
Effective date
2026-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Binosto - Radius Health, Inc. | Polpharma S.A. | SwissCo Services AGRadius Health, Inc. | Polpharma S.A. | SwissCo Services AG2026-02-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
70539-400-042025-02-24These 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
70539-400-942025-02-24These 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
70539-400-042025-01-30These 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
70539-400-942025-01-30These 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 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 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

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 2 of 28 · 550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c7e470d6-508e-466e-a78d-060bbbc9745c2026-07-03Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirst9ee46a5b-d00e-4254-e053-2995a90aeb3a2026-06-29Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
ALENDRONATE SODIUMALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.54d6543d-4239-58b1-e054-00144ff88e882026-06-23Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
ALENDRONATE SODIUMALENDRONATE SODIUMREMEDYREPACK INC.c4358ba7-1bf8-4b0a-9407-5ac279d045552026-06-22Warnings, Adverse reactionsExact identifier
unii: 2UY4M2U3RA
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirstd8516f38-6f92-32d1-e053-2995a90a96bf2026-06-19Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.