NDC 51688-9650 - 15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY

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
51688-9650
Package NDCs from labels
51688-9650-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.
Effective date
2012-07-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHYSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.2012-07-25MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT815919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFP15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394RO15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X415919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI20098715919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CATIONACTIVE MOIETYLYR4M0NH3715919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CB15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA7415919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0R15919-20 PORTEX SINGLE SHOT EPIDURAL 20G TUOHY () 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 52 of 71 · 1,420 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUPIVACAINE HCI AND EPINEPHRINEBUPIVACAINE HCI AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst99516811-56e2-9c8a-e053-2a95a90ac9cb2024-01-30Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)SENSORCAINE(R) (BUPIVACAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst946ce625-3647-5083-e053-2a95a90a1ebc2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirste3b3b462-8f35-68b8-e053-2995a90a64032024-01-27Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirsta14ca7d9-de30-a303-e053-2a95a90a53042024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste39435a3-1f69-78c5-e053-2995a90a7fc32024-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA080408
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirste5247ed5-6170-c13f-e053-2a95a90a41012024-01-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
XYLOCAINE- MPF (LIDOCAINE HCl )LIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste8b987c8-b5cb-74cd-e053-2a95a90a5a932024-01-27Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
CIRCULATION HPARNICA MONTANA, AURUM METALLICUM, CACTUS GRANDIFLORUS, CALCAREA CARBONICA, LACHESIS MUTUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, SOLIDAGO VIRGAUREA,Energique, Inc.464d208b-3893-4ec6-9868-12ef6807b98d2024-01-23WarningsExact identifier
unii: 451W47IQ8X
DERMA SCALE HPARSENICUM IODATUM, BORAX, GRAPHITES, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PETROLEUM, SEPIA, SULPHUREnergique, Inc.64961787-7e9a-4e6f-98ce-0f51934155cf2024-01-23WarningsExact identifier
unii: 451W47IQ8X
XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)XYLOCAINE(R) -MPF (LIDOCAINE HCI AND EPINEPHRINE)HF Acquisition Co LLC, DBA HealthFirst971439ed-4507-7a30-e053-2a95a90a1f1c2024-01-22Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
LIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINELIDOCAINE HCI AND EPINEPHRINE WITH EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirst94e9f2db-af29-032e-e053-2995a90a7f7b2024-01-22Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
BUPIVACAINE HCIBUPIVACAINE HCIHF Acquisition Co LLC, DBA HealthFirste37e1599-db88-2fcd-e053-2995a90a00e52024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
BUPIVACAINE HYDROCHLORIDE injection, solutionBUPIVACAINE HYDROCHLORIDE INJECTION, SOLUTIONHF Acquisition Co LLC, DBA HealthFirst06c15208-c600-7173-e063-6394a90a2f942024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirst0c6c5678-e987-b822-e063-6394a90ac88b2024-01-22Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
Energy ComplexECHINACEA (ANGUSTIFOLIA), LAPPA MAJOR, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ADRENALINUM, ALOE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, BRYONIA (ALBA), CHELIDONIUM MAJUS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, FERRUM METALLICUM, GLONOINUM, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, IODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, RHUS TOX, RUTA GRAVEOLENS, THUJA OCCIDENTALIS, THYROIDINUM (BOVINE)Health Masters LLC9286ca29-8190-4867-9231-b0d68180cb102024-01-22WarningsExact identifier
unii: 451W47IQ8X
Pain ReliefLIDOCAINE, MENTHOLHUMN Pharmaceuticals Inc6c96f94a-e724-eab3-e053-2991aa0aab882024-01-17WarningsExact identifier
unii: EC2CNF7XFP
Sodium ChlorideSODIUM CHLORIDESpectra Medical Deviecs, LLC7e316d21-d6ad-4976-bd90-268fd7e513612024-01-12Adverse reactionsExact identifier
application number: ANDA206171
ndc (package): 65282-1505-1
ndc (product): 65282-1505
rxcui: 1807646
rxcui: 1807637
spl id: 447bf261-1a3a-2da1-e063-6394a90a7537
spl set id: 7e316d21-d6ad-4976-bd90-268fd7e51361
unii: 451W47IQ8X
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE ANHYDROUSSpectra Medical Devices, LLCe8ba012a-08a9-4f67-9f88-3284377e80be2024-01-12Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
A01 CELLULAR RECHARGEACETICUM ACIDUM, ARNICA MONTANA, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CEANOTHUS AMERICANUS, CERATOSTIGMA ILLMOTTIANUM, CHININUM ARSENICOSUM, CITRICUM ACIDUM, ENGLISH ELM, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, HYDROFLUORICUM ACIDUM, JUGLANS REGIA, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SILICOFLUORICUM, NATRUM SULPHURICUM, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREAApex Energetics Inc.b932ebd3-afea-6a95-e053-2995a90a27352024-01-08WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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