FDA.reportPublic FDA data

NDC 51688-6482 - A4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE

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
51688-6482
Package NDCs from labels
51688-6482-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2015-03-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
A4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRESmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd.2015-03-23MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8A4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394ROA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
EPINEPHRINEACTIVE MOIETYYKH834O4BHA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987A4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH37A4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
ANHYDROUS DEXTROSEINACTIVE INGREDIENT5SL0G7R0OKA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RA4166-17/25 COMBINED SPINAL/EPIDURAL 17G TUOHY/25G WHITACRE () KIT [SMITHS MEDICAL ASD, 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 13 of 102 · 2,033 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Anxiety ReliefACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI CARBONICUM, MOSCHUS, NATRUM MURIATICUM, PIPER METHYSTICUMNaturalCare9f982e89-655c-49be-85d8-4099a02ed0212026-04-15WarningsExact identifier
unii: 451W47IQ8X
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Pharma Nobis, LLC4f6d9a51-c42e-ca88-e063-6394a90a86592026-04-14WarningsExact identifier
unii: V13007Z41A
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDECardinal Health 107, LLC8f8f4ece-de78-4c13-8d9f-c3bb7053019d2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.c3490a23-14c4-43f7-b066-96a4c4298fde2026-04-14Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
unii: V13007Z41A
BUPIVACAINE HYDROCHLORIDEBUPIVACAINE HYDROCHLORIDEHospira, Inc.bb44c7e1-d911-4788-908f-09b7b271969b2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
SODIUM CHLORIDE 1 GRAMSODIUM CHLORIDEGendose Pharmaceuticals, LLCce988ae5-61c6-4324-90e1-a94c8a54d0d02026-04-13WarningsExact identifier
unii: 451W47IQ8X
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: YKH834O4BH
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: 451W47IQ8X
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: 451W47IQ8X
neffyEPINEPHRINEARS Pharmaceuticals Operations, Inc.a1758142-a905-401d-8961-05829f51023a2026-04-09Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
AdrenalinEPINEPHRINEPar Health USA, LLCa5ce0c01-dd47-4997-ab09-490de65d38352026-04-08Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
AdrenalinEPINEPHRINEPar Health USA, LLCb27e06aa-5b40-44bc-8de7-80b027580a3b2026-04-08Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
unii: V13007Z41A
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: 451W47IQ8X
Bupivacaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.7a8d2539-4422-4312-0298-207ef1a2948e2026-04-07Warnings, Adverse reactionsExact identifier
application number: ANDA071810
ndc (package): 0409-3613-01
ndc (product): 0409-3613
rxcui: 1724784
spl id: 7a09a90d-26da-42bd-bb54-2d2102eb8c1c
spl set id: 7a8d2539-4422-4312-0298-207ef1a2948e
unii: 7TQO7W3VT8

Reported adverse events (FAERS/openFDA)#

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