FDA.reportPublic FDA data

NDC 51688-8648 - A2487-18 PORTEX SINGLE SHOT EPIDURAL

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
51688-8648
Package NDCs from labels
51688-8648-2
Manufacturer
Smiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.
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
A2487-18 PORTEX SINGLE SHOT EPIDURALSmiths Medical ASD, Inc. | Hospira, Inc. | Kwang Myung Pharm. Co., Ltd. | Aplicare, Inc.2012-11-29MEDICAL DEVICE

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BUPIVACAINE HYDROCHLORIDEACTIVE INGREDIENT7TQO7W3VT8A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINE HYDROCHLORIDE ANHYDROUSACTIVE INGREDIENTEC2CNF7XFPA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
BUPIVACAINEACTIVE MOIETYY8335394ROA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
CHLORIDE IONACTIVE MOIETYQ32ZN48698A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
IODINEACTIVE MOIETY9679TC07X4A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9TA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IA2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74A2487-18 PORTEX SINGLE SHOT EPIDURAL () KIT [SMITHS MEDICAL ASD, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RA2487-18 PORTEX SINGLE SHOT EPIDURAL () 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 8 of 109 · 2,167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
LidovyxLIDOCAINE 4%V2 Pharma LLC4465eb60-a617-4608-9504-8b3b4c64f49e2026-06-30WarningsExact identifier
unii: V13007Z41A
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
unii: V13007Z41A
GNP Lidocaine Maximum StrengthLIDOCAINE HCLAMERISOURCE BERGEN9f559c20-c9ac-e480-e053-2a95a90a8fce2026-06-29WarningsExact identifier
unii: V13007Z41A
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst76176d50-a987-c9f9-e053-2991aa0aea0f2026-06-29Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
Nervionoix Pro Neuropathy Fast Acting CreamLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated23abdf62-03a8-4aaa-8e29-0e2585b5ade72026-06-24WarningsExact identifier
unii: V13007Z41A
CVS Povidone IodinePOVIDONE IODINECVS Pharmacy Inca8d754f4-a696-d0d9-e053-2a95a90a4aff2026-06-24WarningsExact identifier
unii: 85H0HZU99M
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
MarcaineBUPIVACAINE HYDROCHLORIDEHenry Schein, Inc.2c6f9b85-e783-4ad4-a804-a0ff1a32ec2c2026-06-24Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
Swab Applicator Brushes Iodine (0.7% Available Iodine) and Isopropyl Alcohol (74% w/w)IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD54e83df5-bbeb-d068-e063-6394a90ad5132026-06-23WarningsExact identifier
unii: 85H0HZU99M
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
Marcaine SpinalBUPIVACAINE HYDROCHLORIDE IN DEXTROSEHospira, Inc.9679cc05-2f8a-4e88-53b5-6e9122c8b8c02026-06-23Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
BUPIVACAINE HClBUPIVACAINE HCLHF Acquisition Co LLC, DBA HealthFirste391f807-7699-6d82-e053-2a95a90ab6412026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7TQO7W3VT8
PVP-I Prep PadPOVIDONE-IODINEProfessional Disposables International, Inc.57b02fbb-a9a6-0b8c-e063-6394a90a44f32026-06-22WarningsExact identifier
unii: 85H0HZU99M
XYLOCAINE-MPF WITH EPIXYLOCAINE-MPF WITH EPIHF Acquisition Co LLC, DBA HealthFirstc5dcb0e5-2624-9c9c-e053-2995a90a6d652026-06-19Warnings, Adverse reactionsExact identifier
unii: EC2CNF7XFP
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09613b2-4337-5b52-e053-2995a90ab74b2026-06-19Warnings, Adverse reactionsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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