FDA.reportPublic FDA data

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 61 of 71 · 1,417 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 451W47IQ8X
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLC3335dabe-66d5-440b-a59a-b62993030e0f2023-06-09Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HClBUPIVACAINE HYDROCHLORIDEXellia Pharmaceuticals USA LLCf29c905e-9a55-446f-a89d-860ad9ade7ad2023-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: 451W47IQ8X
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC694926ac-aff0-aa1f-e053-2991aa0a95882023-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sensorcaine MPFBUPIVACAINE HYDROCHLORIDEFresenius Kabi USA, LLCe700eb7b-8b14-49c9-96b2-331f18776e452023-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCada6a9bf-f7cb-035a-e053-2a95a90a6a3d2023-05-03Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Bupivacaine HydrochlorideBUPIVACAINE HYDROCHLORIDEMedical Purchasing Solutions, LLCd1642239-4230-b679-e053-2a95a90a3b7c2023-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
SENSORCAINEBUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEFresenius Kabi USA, LLCbc61a9a6-0a4e-48a9-b908-e5e66b9f23eb2023-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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