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 16 of 39 · 765 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.4ff72575-bd60-40ce-b3a8-fd92b79af6742025-11-07Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack49659ee7-ca08-4df1-8e6b-3a366a7839c72025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 866018
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackeb072818-3ca8-430b-91a1-e7fedd37990c2025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 866090
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackaba814f0-55ce-4480-99f1-b9ad1ba77d3f2025-11-03Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepackbee0edbf-3fc3-484b-9715-f13a329216ae2025-11-03Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions38677cd0-2ee6-4c8f-8553-36310b2813a12025-11-02Warnings, Adverse reactionsExact identifier
rxcui: 866090
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEBryant Ranch Prepack4e7640d1-0a31-4f97-82bb-574cf1ff6e4a2025-10-28Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Miranda Castros Healing Cell Salts For Bones, Hair, Nails, and TeethCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC267fb775-a03c-f100-e063-6394a90aa8262025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4
Miranda Castros healing cell salts for bones, hair, nails and teeth Homeopathic CombinationCALCAREA FLUORICA, CALCAREA PHOSPHORICA, SILICEAMIRANDA CASTRO'S SHOP, LLC266e907b-4cdb-fb4f-e063-6394a90aa4342025-10-23WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD41157552-2473-176b-e063-6294a90a9ad02025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd4115d122-3090-d3e5-e063-6294a90aafb62025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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