FDA.reportPublic FDA data

NDC 49252-101-54 - BusPIRone Hydrochloride

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
49252-101
Requested NDC
49252-101-54
Package NDCs from labels
49252-101-54, 49252-101-57, 49252-101-11, 49252-101-13, 49252-101-17, 49252-101-18
Manufacturer
Inventia Healthcare Private Limited
Effective date
2018-05-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BusPIRone Hydrochloride - Inventia Healthcare Private LimitedInventia Healthcare Private Limited2018-05-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
49252-101-11Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included)
49252-101-13Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included)
49252-101-17Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included)
49252-101-18Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included)
49252-101-57Buspirone Hydrochloride Tablets USP (Patient Instruction Sheet Included)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49252-101-11BusPIRone Hydrochloride60 in 1 BOTTLETABLET601
49252-101-13BusPIRone Hydrochloride100 in 1 BOTTLETABLET1001
49252-101-17BusPIRone Hydrochloride500 in 1 BOTTLETABLET5001
49252-101-18BusPIRone Hydrochloride1000 in 1 BOTTLETABLET10001
49252-101-54BusPIRone Hydrochloride10 in 1 BLISTER PACKTABLET101
49252-101-57BusPIRone Hydrochloride10 in 1 CARTONTABLET101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49252-101BUSPIRONE HYDROCHLORIDE TABLET [INVENTIA HEALTHCARE PRIVATE LIMITED]1Legacy NDC, 6 package rows20180517_3c543c3d-109c-455c-91fb-277ef77cabad.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 38 of 38 · 743 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: ETJ7Z6XBU4
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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