FDA.reportPublic FDA data

NDC 68382-182-30 - 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
68382-182
Requested NDC
68382-182-30
Package NDCs from labels
68382-182-30, 68382-182-77, 68382-182-14, 68382-182-01, 68382-182-28, 68382-182-05, 68382-182-10
Manufacturer
Major Pharmaceuticals
Effective date
2026-06-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Buspirone hydrochloride - Major PharmaceuticalsMajor Pharmaceuticals2026-06-30HUMAN PRESCRIPTION DRUG LABEL
Buspirone Hydrochloride Tablets, USPUnit Dose Solutions, Inc.2026-06-15HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - AvPAKAvPAK2026-03-04HUMAN PRESCRIPTION DRUG LABEL
BUSPIRONE - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2025-02-12HUMAN PRESCRIPTION DRUG LABEL
Buspirone Hydrochloride Tablets, USPREMEDYREPACK INC.2025-01-09HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - American Health PackagingAmerican Health Packaging2024-06-07HUMAN PRESCRIPTION DRUG LABEL
Buspirone Hydrochloride Tablets, USPREMEDYREPACK INC.2024-02-14HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2022-02-09HUMAN PRESCRIPTION DRUG LABEL
Buspirone Hydrochloride Tablets, USPPreferred Pharmaceuticals Inc.2021-10-27HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - A-S Medication SolutionsA-S Medication Solutions2021-03-08HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-12-30HUMAN PRESCRIPTION DRUG LABEL
Buspirone Hydrochloride Tablets, USPNuCare Pharmaceuticals,Inc. | NuCare Pharmaceuticals, Inc.2020-01-21HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - Unit Dose ServicesUnit Dose Services2019-09-20HUMAN PRESCRIPTION DRUG LABEL
Buspirone hydrochloride - Aphena Pharma Solutions - Tennessee, LLCAphena Pharma Solutions - Tennessee, LLC2018-12-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-182-01Buspirone hydrochloride100 in 1 BOTTLETABLET10011
68382-182-05Buspirone hydrochloride500 in 1 BOTTLETABLET50011
68382-182-10Buspirone hydrochloride1000 in 1 BOTTLETABLET100011
68382-182-14Buspirone hydrochloride60 in 1 BOTTLETABLET6011
68382-182-28Buspirone hydrochloride180 in 1 BOTTLETABLET18011
68382-182-30Buspirone hydrochloride1 in 1 BLISTER PACKTABLET111
68382-182-77Buspirone hydrochloride100 in 1 CARTONTABLET10011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-182BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 7 package rows20250214_14fd7c1c-778e-46d4-9024-89b319f15f39.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-182-01EA - Each68382-18215f54f8e-721c-46e9-80b7-4127a841525b12014-12-01
68382-182-05EA - Each68382-1826384983e-312e-4abb-b114-6d5438ac2b9a12014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3
BUSPIRONE HYDROCHLORIDEACTIVE INGREDIENT207LT9J9OCBUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
BUSPIRONEACTIVE MOIETYTK65WKS8HLBUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUSPIRONE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1

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 3 of 39 · 772 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEGolden State Medical Supply, Inc.bcce49d3-c8eb-9f9b-e053-2995a90a67d92026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866111
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEA-S Medication Solutions7b222cb0-0061-4a3e-9d0f-e9f120e7f5d92026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDERedpharm Drug5718bc19-07b2-b61d-e063-6394a90a6e802026-07-21Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.a9fc7091-b3ce-45fd-8d89-aeebdd81c3272026-07-16Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEStrides Pharma Inc.cb0091ad-97f6-431b-b2b9-e03171eed2742026-07-08Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866111
rxcui: 866090
rxcui: 866094
rxcui: 866018
unii: 207LT9J9OC
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEREMEDYREPACK INC.b42cc365-6259-4d2e-9648-d37718b65e1e2026-06-30Warnings, Adverse reactionsExact identifier
rxcui: 866094
unii: 207LT9J9OC
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEMajor Pharmaceuticalsa9bb9216-3dac-4e8a-9df9-f72c2eaef1602026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA078888
ndc (package): 0904-6899-61
ndc (product): 0904-6899
rxcui: 866018
spl id: bfbad05f-e3f7-48e2-835a-95d34d8a43bf
spl set id: a9bb9216-3dac-4e8a-9df9-f72c2eaef160
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEIPG Pharmaceuticals, Inc2c516eec-65d9-4481-8823-ae6b6da840622026-06-21Warnings, Adverse reactionsExact identifier
unii: 207LT9J9OC
busPIRone HClBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLC472049d2-c4d9-5a38-e063-6294a90a5cf12026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 866111
unii: 207LT9J9OC
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDENorthwind Health Company, LLC1d883a13-4877-c6c7-e063-6294a90a51372026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 866083
unii: 207LT9J9OC
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone HydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544a4570-bd7f-72bb-e063-6394a90ab8d62026-06-15Warnings, Adverse reactionsExact identifier
rxcui: 866083
rxcui: 866094
unii: 207LT9J9OC
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Buspirone hydrochlorideBUSPIRONE HYDROCHLORIDEUnit Dose Solutions, Inc.544b8918-7175-655f-e063-6394a90a453a2026-06-15Warnings, Adverse reactionsExact identifier
application number: ANDA078888
ndc (package): 87441-019-01
ndc (product): 87441-019
rxcui: 866018
spl id: 544b9562-a254-1d5e-e063-6294a90aac20
spl set id: 544b8918-7175-655f-e063-6394a90a453a
unii: 207LT9J9OC

Reported adverse events (FAERS/openFDA)#

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