FDA.reportPublic FDA data

NDC 51688-8367 - A2503-18 SINGLE SHOT EPIDURAL 18G 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
51688-8367
Package NDCs from labels
51688-8367-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.
Effective date
2012-11-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
A2503-18 SINGLE SHOT EPIDURAL 18G TUOHYSmiths Medical ASD, Inc. | Hospira, Inc. | Aplicare, Inc. | Kwang Myung Pharm. Co., Ltd.2012-11-29MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
LidocaineACTIVE MOIETY98PI200987A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IA2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74A2503-18 SINGLE SHOT EPIDURAL 18G TUOHY () KIT [SMITHS MEDICAL ASD, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RA2503-18 SINGLE SHOT EPIDURAL 18G 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 81 of 106 · 2,108 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
unii: V13007Z41A
Natrum MuriaticumSODIUM CHLORIDESEVENE USA11008014-fff6-4d5a-8c5c-a20443d7cc232024-01-30WarningsExact identifier
unii: 451W47IQ8X
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst8c63be55-5de4-7f72-e053-2995a90a102e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
1% LIDOCAINE HCI1% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst999dd95d-87fe-12c0-e053-2995a90aa9f72024-01-30Warnings, Adverse reactionsExact identifier
rxcui: 1010033
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4bf5905-add7-1cb0-e053-2995a90a73342024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirstc4c0df51-cc37-323d-e053-2995a90a154a2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals7a664a34-19fd-4a7b-ab4d-11299b32999e2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticalsfd6343a9-15a6-4894-b51f-122e4d6dbe792024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDESeton Pharmaceuticals1c0abe84-5404-404e-b882-e910e4d43ffb2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals951862db-3a73-4d25-9d5b-e4111833f43b2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Lidocaine Hydrochloride and Hydrocortisone AcetateLIDOCAINE HYDROCHLORIDE AND HYDROCORTISONE ACETATESeton Pharmaceuticals6aa284d6-0212-4fb5-809d-c721aa6fe2ba2024-01-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst993bc59e-5e71-bd9e-e053-2a95a90af85c2024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
2% LIDOCAINE HCI2% LIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst78d8fb0a-bfae-6599-e053-2991aa0a2e032024-01-28Warnings, Adverse reactionsExact identifier
rxcui: 1010671
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirstc4c16714-6b1f-857e-e053-2a95a90a74e42024-01-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
XYLOCAINEXYLOCAINEHF Acquisition Co LLC, DBA HealthFirste3b3b462-8f35-68b8-e053-2995a90a64032024-01-27Warnings, Adverse reactionsExact identifier
rxcui: 1010033
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 HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirstc901016e-9293-79dd-e053-2a95a90a0fda2024-01-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste8bc96bc-7876-4906-e053-2a95a90ae6ba2024-01-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LIDOCAINE HClLIDOCAINE HCLHF Acquisition Co LLC, DBA HealthFirste39435a3-1f69-78c5-e053-2995a90a7fc32024-01-27Warnings, Adverse reactionsExact identifier
application number: ANDA080408
rxcui: 1737568
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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